Infant Gastrointestinal Symptoms Questionnaire Research Articles

Effects of Limosilactobacillus reuteri DSM 17938 in neonates exposed to antibiotics: a randomised controlled trial.

Perinatal antibiotic exposure potentially leads to gut microbiota dysbiosis, which is associated with functional gastrointestinal disorders (FGIDs). We aimed to investigate the effects of Limosilactobacillus reuteri DSM 17938 supplementation on the development of FGIDs, crying and sleep duration, and the gut microbial composition in infants exposed to antibiotics during the neonatal period. In this randomised, double-blind, placebo-controlled study, we included 89 term neonates treated with antibiotics. Neonates received the study product for six weeks. FGIDs, assessed by the Infant Gastrointestinal Symptom Questionnaire, crying and sleep duration were assessed at four and eight weeks, and six months after enrolment. Faecal samples were collected six weeks and twelve months after enrolment. The gut microbial community composition was analysed using 16S amplicon sequencing and qPCR. The proportion of infants with FGIDs was greater in the control group, although the difference between the groups was significant only six months after enrolment. At all time points, the probiotic group presented a longer sleep duration and shorter crying time than the control group, but the difference was not statistically significant. Probiotic consumption had no significant effect on the gut microbiota composition except for increased L. reuteri DSM 17938 abundance in the probiotic group at six weeks after enrolment. At specific time points after supplementation with L. reuteri DSM 17938, a reduction in the prevalence of FGIDs was observed in the probiotic group. However, no observable effect on the gut microbiota was detected during the intervention. We believe that probiotic supplementation in neonates during and after antibiotic treatment to minimise the negative effects of antibiotics on gut function during this vulnerable period of human development warrants further investigation. The trial is registered at ClinicalTrials.gov (NCT02865564).

Follow-up study of three cases of congenital microgastria.

Current knowledge on congenital microgastria is limited due to its extreme rarity, and the paucity of nutritional and quality of life follow-ups. Patients affected by congenital microgastria cases followed at out center were screened, and general and nutritional status were evaluated at follow-up visits through validated questionnaires. Three cases were included: one patient died because of a complex syndromic picture where microgastria was imperatively approached conservatively. The remaining cases underwent Hunt-Lawrence at 2 and 17 months. After 2 years and 27 years postoperatively, both patients are on full oral intake. The 28-yearold patient did not reach a BMI higher than 18. She rated her quality of life as unimpacted, with a Gastrointestinal Quality of Life Index of 111. In the other case, parents reported about their 2-yearold child an Infant Gastrointestinal Symptom Questionnaire of 13, corresponding to "no distress". Our findings confirm the literature trend supporting the role of early surgery in microgastria to improve outcomes. We presented the nutritional status and quality of life in two cases of congenital microgastria operated according to Hunt-Lawrence at a 2-year and 27-year distance, which is the longest follow-up reported to date.

Efficacy of an extensively hydrolyzed formula with the addition of synbiotics in infants with cow's milk protein allergy: a real-world evidence study.

Cow's milk protein allergy (CMPA) is the most frequent food allergy in early childhood. For those infants requiring breastmilk substitutes, formulas with extensively hydrolyzed proteins (EHF), should be the treatment of choice. As there are limited data showing the progression of initial symptoms in infants newly diagnosed with CMPA who are treated with EHF with added synbiotics, the main objective of this study was to evaluate the resolution of symptoms in said infants after 4 weeks of treatment. As a secondary objective this study aimed to assess the impact of the treatment on the family's quality of life. observational, longitudinal, prospective, and multicentric real-world evidence study. The intervention phase (EHF with synbiotics) lasted 28 days and was completed by 65 patients. Treating physicians registered child´s anthropometry, Infant Gastrointestinal Symptoms Questionnaire (IGSQ-13) and CoMiSS (Cow´s Milk Allergy Symptoms Score) both at baseline and after 28 days of treatment. During treatment, caregivers reported child´s regurgitation and stools, PO-SCORAD (Patient Oriented Scoring of Atopic Dermatitis) and FAQL-PB (Family Quality of Life-Parental Burden). Data were collected using Google Forms and analyzed through the STATA program. 95.4% of the patients showed an improvement or disappearance of the overall initial symptoms after 4 weeks of treatment. Gastrointestinal symptoms improved or disappeared in 92% of patients (p < 0.05) while dermatological symptoms improved or disappeared in 87.5% of patients (p < 0.05). The median CoMiSS at baseline was 9, with 21 patients exceeding the cut-off point of 12. After 4 weeks of treatment, the median dropped to 3, and no patient exceeded the 12-cut-off point (p = 0.000). At baseline, patients had a PO-SCORAD of 11.5 (interquartile range 1-23) that went to 1.0 (interquartile range 1-6) at day 28 (p = 0.000). The treatment diminished stool frequency (p < 0.05), improved stool consistency (p = 0.004) and decreased the frequency of regurgitation in infants with CMPA (p = 0.01). The percentage of patients who no longer had any episode of regurgitation increased from 11% to 31% on day 28 (p = 0.003). At baseline, 13% of patients cried more than 3 h per day, while at day 28 that percentage dropped to 3% (p = 0.03). An improvement in the infants' sleep pattern was also appreciated with the treatment. At study onset, 56% of the families reported feeling very overwhelmed, a percentage that dropped to 17% after 28 days of treatment (p < 0.05). The small percentage of families who did not feel overwhelmed at study onset (17%), grew to 43% on day 28 (p < 0.05). The use of an EHF with synbiotics for the management of infants diagnosed with or suspected to have CMPA suggested a good safety profile, an adequate infant growth, and improvement of overall, gastrointestinal, and dermatological symptoms. It also suggested a lower daily frequency of regurgitations and stools, and an improvement in stool consistency, sleeping pattern, and quality of life of the infant and his family.

Real-world evidence study on tolerance and growth in infants fed an infant formula with two human milk oligosaccharides vs mixed fed and exclusively breastfed infants

IntroductionHuman milk oligosaccharides (HMOs) are important components of human milk having diverse functions in the development of infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas with the HMOs 2′-fucosyllactose (2′FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This study aimed to generate real-world evidence (RWE) on growth and gastrointestinal (GI) tolerance in infants consuming a formula with 1 g/L 2′FL and 0.5 g/L LNnT, including a mixed feeding group not studied before in RCTs.Participants and methodsThis 8-week open-label prospective multicenter study was conducted in Germany and Austria, and included groups of healthy, exclusively breastfed infants (BF), exclusively formula-fed infants (FF) who received the HMO-formula, and infants mixed fed with both HMO formula and human milk (MF). Co-primary outcomes were anthropometry and gastrointestinal tolerance via validated Infant Gastrointestinal Symptom Questionnaire (IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs).ResultsOne-hundred six infants completed the study (46 FF, 22 MF, and 38 BF). Mean anthropometric z-scores were comparable between groups and generally within ± 0.5 of WHO medians at week 8. IGSQ composite scores demonstrated good GI tolerance in all groups with no significant group differences at week 4 or 8. IGSQ composite scores in FF improved during the course of the study and parents provided high satisfaction ratings for the HMO-formula. Four potentially product-related AEs were reported in FF (no in MF).ConclusionsIn this RWE study examining an infant formula with HMOs, growth and GI tolerance outcomes were confirming the good tolerance and safety of this early feeding option previously reported in RCTs.

Prevalence and Risk Factors of Functional Gastrointestinal Disorders in Infants in Indonesia

Information regarding functional gastrointestinal disorders (FGIDs) in infants is currently lacking in Indonesia. This study aimed to describe the prevalence and risk factors of FGIDs in infants aged 6 weeks to 4 months in Indonesia. This cross-sectional study of 433 infants was conducted between September 2018 and February 2020. Information on FGIDs was collected using the Infant Gastrointestinal Symptom Questionnaire and the Feeding Practice and Gut Comfort Questionnaire. Adapted Rome IV criteria were used to define the FGIDs. The prevalence of regurgitation was 26.3%; 16.8% of the infants presented crying-related symptoms and 5.5% exhibited constipation. The statistical analyses revealed that constipation was associated with sex (odds ratio [OR], 2.74; 95% confidence interval [CI], 1.07-7.71; p=0.043), employment of the father (OR, 0.3; 95% CI, 0.12-0.77; p=0.01), and education of the mother (OR, 1.92; 95% CI, 1.07-3.51; p=0.031). Length at birth (OR, 0.74; 95% CI, 0.55-0.99; p=0.042) was associated with constipation. Length at visit (OR, 0.83; 95% CI, 0.76-0.91; p<0.001) was associated with regurgitation, and the weight at visit (OR, 0.58; 95% CI, 0.35-0.96; p=0.038) was associated with crying and/or colic. A history of parental FGIDs was associated with crying-related symptoms (OR, 2.12; 95% CI, 1.23-3.68; p=0.007). Regurgitation, crying, and constipation are common FGIDs in infants. Some parental and infant characteristics may be predictors for FGIDs. Further investigations are needed to evaluate the clinical relevance of our findings. Understanding the determinants of FGIDs will benefit healthcare professionals and parents to improve infant's quality of life and better manage these condition.

Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study

BackgroundSigns of feeding intolerance, such as gastrointestinal (GI) symptoms, are frequently observed in otherwise healthy formula-fed infants in the first months of life. The primary objective of this observational study was to examine GI tolerance in formula-fed infants (FFI) vs. breastfed infants (BFI) in a real-world setting with a secondary objective being the comparison of infants fed formula with pre- and/or probiotics (FFI_PP) and those fed formula without any pre- and/or probiotics (FFI_noPP) as well as BFI.MethodsA six-country, cross-sectional study in full-term exclusively/predominantly FFI (n = 2036) and BFI (n = 760) aged 6–16 weeks was conducted using the validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) and a Feeding Practice and Gut Comfort Questionnaire.ResultsThe IGSQ composite score in FFI was non-inferior compared to BFI (mean difference [95%CI]: 0.17 [-0.34, 0.67]; non-inferiority p-value < 0.0001) and scores for BFI and FFI were below the threshold of 23, indicating no GI discomfort. Adjusted mean IGSQ scores ± SE were similar in FFI_PP (22.1 ± 0.2) and BFI (22.3 ± 0.3) while FFI_noPP (23.4 ± 0.3) was significantly higher and above 23 indicating some GI discomfort (mean differences [95%CI] FFI_noPP minus FFI_PP and FFI_noPP minus BFI were 1.28 [0.57, 1.98] and 1.09 [0.38, 1.80], respectively; both p < 0.01). Hard stools and difficulty in passing stool were more common in FFI compared to BFI (p < 0.01) but were less common in FFI_PP compared to FFI_noPP (p < 0.01). FFI_PP showed significantly less crying than FFI_noPP and was similar to BFI. Significantly fewer physician-confirmed colic episodes (Rome IV criteria) were reported in FFI_PP compared with FFI_noPP or BFI.ConclusionsIn this real-world observational study, FFI had non-inferior overall GI tolerance compared to BFI. Within FFI, infants receiving formulas with pre- and/or probiotics had a better GI tolerance, improved stooling and less infantile colic compared to those receiving formula without any pre- and/or probiotics and were more similar to BFI.Trial registrationNCT03703583, 12/10/2018 (https://clinicaltrials.gov/ct2/show/NCT03703583).

Feeding at 6-12 months in infants with CHD.

Feeding difficulty is common in infants with CHD. The purpose of this study was to describe the feeding skills and behaviours of infants with CHD at 6-12 months of age and explore relationships between feeding, gastrointestinal distress, and gastroesophageal reflux. Parents of 30 infants with CHD completed online surveys when their infant was 6, 8, 10, and 12 months old. Surveys included parent-report measures of feeding skills (Child Oral and Motor Proficiency Scale), feeding behaviours (Pediatric Eating Assessment Tool), symptoms of gastrointestinal distress (Infant Gastrointestinal Symptoms Questionnaire), and gastroesophageal reflux (Infant Gastroesophageal Reflux Questionnaire-Revised). We found that 95, 32, 67, and 30% of infants were delayed in their feeding skill development at 6, 8, 10, and 12 months, respectively. Symptoms of problematic feeding behaviours were similarly high, with 90, 62, 29, and 38% of infants meeting criteria for problematic feeding at 6, 8, 10, and 12 months, respectively. Feeding skills and behaviours were related but unique contributors. Feeding behaviours were related to both gastrointestinal distress and gastroesophageal reflux, but feeding skills were rarely related to either. Delayed acquisition of feeding skills and problematic feeding were common in infants with CHD. Infants with more gastrointestinal and gastroesophageal reflux symptoms had more symptoms of problematic feeding behaviours. Comprehensive assessment, targeted interventions, and early involvement of feeding specialists are important to support feeding in infants with CHD through at least the first year of life.

Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial.

ABSTRACTObjectives:A novel anti-regurgitation (AR) formula has been designed to support gut health and improve gastrointestinal (GI) symptoms beyond regurgitation. This study assessed the tolerance and safety of this new AR formula.Methods:This was a 4-week double-blind, randomized, controlled trial with a 4-week extension in formula-fed infants with regurgitation. The new AR (Test) formula contained 0.4 g/100 mL locust bean gum (LBG) as thickener, partly fermented formula with postbiotics, and short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS) (0.4 g/100 mL, ratio 9:1). The Control AR formula contained LBG (0.4 g/100 mL) with postbiotics and has a history of safe use. The primary outcome was the Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum score including stooling, spitting-up/vomiting, crying, fussiness and flatulence.Results:All 182 infants screened were enrolled in the study. The primary analysis showed the equivalence of the IGSQ sum scores at Week 4 between groups. IGSQ sum scores improved significantly within 1 week (Mixed Model Repeated Measurement [MMRM], P < 0.001). Post-hoc analyses showed a bigger improvement of the IGSQ score in the Test (n = 38) versus Control (n = 44) group (MMRM, P = 0.008) in infants with more severe gastrointestinal (GI) symptoms (IGSQ score ≥35). Stool characteristics were comparable between groups. Growth related z scores were in line with the WHO child growth standards and both groups showed improvement of regurgitation. Adverse events did not show any safety concerns.Conclusions:The novel AR formula combining LBG, scGOS/lcFOS and postbiotics is well-tolerated, safe and supports adequate growth during the intervention. Post-hoc analyses suggest that the formula results in more improvement of GI symptom burden in infants with more severe symptoms.

The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers

The purpose of this study was to describe the development of the Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers, and determine its factor structure and psychometric properties. Items were developed to comprehensively assess gastrointestinal (GI) and gastroesophageal reflux (GER) symptoms observable by a parent. Exploratory factor analysis on 391 responses from parents of children under 2 years old resulted in a 36-item scale with 3 subscales. Internal consistency reliability was acceptable (α = .78-.94). The GIGER total score and all 3 subscales were correlated with the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) (P < .05) and Infant Gastrointestinal Symptoms Questionnaire (IGSQ) (P < .05). GIGER total score was higher in infants with a diagnosis of GER (P < .05) or constipation (P < .05) compared to those without. The GIGER is a parent-report measure of GI and GER symptoms in children under 2 years old with adequate psychometric properties.

Abstract 14053: Problematic Feeding is Common and Related to Gastroesophageal Reflux in the First 6 Months After Neonatal Cardiac Surgery

Introduction: Feeding problems are often reported in infants after cardiac surgery. To date, no studies have followed the development of feeding after cardiac surgery using valid and reliable measures. Purpose: To describe feeding problems and the relationship between feeding and gastrointestinal tract symptoms in infants over the first 6 months (mos) after neonatal cardiac surgery. Methods: Parents of neonates requiring cardiac surgery were invited to complete surveys when their infant was 2, 4, and 6 mos old. The survey included the Neonatal Eating Assessment Tool (NeoEAT), Infant Gastroesophageal Reflux Questionnaire – Revised (I-GERQ-R), and Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Scores on the NeoEAT subscales ( Infant Regulation, Energy &amp; Physiologic Stability, Gastrointestinal Tract Function, Sensory Responsiveness , and Compelling Symptoms of Problematic Feeding) were categorized as problematic (≥ 90 th percentile) or not problematic (&lt; 90 th percentile) based on reference data. Percent of the sample with problematic feeding at each time point was determined. Bivariate correlations were calculated between the NeoEAT, IGSQ, and I-GERQ-R. Results: 27 parents completed the surveys, reporting on 6 infants with single ventricle and 21 with two ventricle conditions. Problematic feeding scores were common at all times and in both cardiac conditions. Problematic scores were reported on Compelling Symptoms of Problematic Feeding for 52% of the sample at 2 mos, 36% at 4 mos, and 22% at 6 mos. Problematic scores occurred in Gastrointestinal Tract Function for 22% at 2 mos, 10% at 4 mos, and 39% at 6 mos. Problems occurred in Sensory Responsiveness in 17% at 2 mos, 24% at 4 mos, and 33% at 6 mos. Energy &amp; Physiologic Stability problems occurred in 13%, 10%, and 22%, respectively. None reported problems in Infant Regulation . Symptoms of gastroesophageal reflux (I-GERQ-R) were significantly correlated with the NeoEAT ( p &lt; .05), but gastrointestinal symptoms (IGSQ) were not. Conclusions: Problematic feeding is common in the first 6 mos after neonatal cardiac surgery and is related to gastroesophageal reflux symptoms. Some areas of feeding improved over time, while others worsened, likely related to developmental and disease-related changes.

Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula with a New Lipid Blend and Lactobacillus reuteri (L.reuteri): A Randomized Controlled Trial

Abstract Objectives Differences in dietary fat and calcium absorption between breastfed and formula-fed infants may impact gastrointestinal (GI) tolerance and stooling patterns. We hypothesized that infant formula containing L. reuteri and a new lipid blend with low levels of long-chain saturated fatty acids (LCSFAs) (&amp;lt;13% of triacylglycerols [TAG]) in sn-1,3 positions would result in reduced stool calcium-fatty acid (Ca-FA) soaps and improved stool consistency. Methods Healthy term infants 21–28 days (d) of age were randomized in a double-blind manner to receive intact protein cow's milk-based experimental formula (EF, n = 70) with new lipid blend and L. reuteri at 1 × 10,7 CFU/g or control formula (CF, n = 70) without probiotic and containing a lipid blend with high levels of LCSFAs (∼25% of TAG) in sn-1,3 positions until 3 months (m) of age. A breastfed (BF, n = 75) reference group was also included. Co-primary endpoints were stool consistency (via 3-day diary using validated scale from 1 = watery to 5 = hard) and stool total Ca-FA soaps (expressed as mg/g dry stool weight). Overall GI tolerance was assessed using a validated Infant Gastrointestinal Symptoms Questionnaire (IGSQ) (score range: 13 [no GI distress] - 65 [extreme GI distress]). Results Of 215 enrolled infants, 206 completed the study. Infants fed EF had softer stools vs those fed CF by age 1.5 m (stool consistency score: 2.6 ± 0.1 vs 3.0 ± 0.1, P &amp;lt; .0001) and similar to BF (2.7 ± 0.1, P = .089). This positive effect was sustained until age 3 m (EF vs CF, P = .0006; EF vs BF, P = .373; CF vs BF, P = .014), without increased stool frequency in EF vs CF group throughout the study (1.48 vs 1.50 stools/d, P = .884). Infants fed EF (vs CF) had lower stool total Ca-FA soaps at 3 m of age (60.3 ± 10.1 vs 207.9 ± 10.1, P &amp;lt; .0001), largely explained by stool palmitate soaps which was 7 times lower in EF vs CF (20.7 ± 7.0 vs 142.5 ± 6.9 for CF, P &amp;lt; .0001). Mean IGSQ scores remained very low in EF (≤16.2) and CF (≤15.6) groups over the study period. Incidences of parent-reported GI symptoms and physician-confirmed GI adverse events (including diarrhea) were low and similar for EF and CF groups. Conclusions Infant formula containing L. reuteri and enhanced lipid blend with reduced LCSFAs in sn-1,3 positions reduces stool soaps and promotes softer stools closely resembling the stools of breastfed infants. Funding Sources Sponsored by Nestle Nutrition.

Gastrointestinal Symptoms in Healthy, Full-Term Infants Under 7 Months of Age

PurposeTo describe symptoms of gastrointestinal distress experienced by healthy, full-term infants in the first 7 months of life and test the psychometric properties of the Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Design and methodsParents of infants <7 months (n = 320) completed the IGSQ, the Infant Gastroesophageal Reflux Questionnaire – Revised (I-GERQ-R), and the Neonatal Eating Assessment Tool (NeoEAT) – Breastfeeding and/or Bottle-feeding. Median and percentile scores were calculated for the IGSQ scores for each age group: 0–2, 2–4, 4–6, and 6–7 months. Change in IGSQ scores with age were evaluated using the Kruskal-Wallis test with Mann-Whitney U tests for post-hoc comparisons. Internal consistency reliability was assessed using Cronbach's alpha. Concurrent validity was tested using Spearman's rho between the IGSQ and the I-GERQ-R and NeoEAT. ResultsIGSQ scores decreased significantly with increased infant age, from a median of 28 at 0–2 months to 23 at 6–7 months old. The IGSQ had acceptable internal consistency reliability (Cronbach's alpha = 0.74). IGSQ total score was significantly correlated with I-GERQ-R total score (Spearman's rho (rs) = 0.69, p < .001), NeoEAT – Breastfeeding: Gastrointestinal Function subscale score (rs = 0.46, p < .001), and NeoEAT – Bottle-feeding: Gastrointestinal Tract Function subscale score (rs = 0.47, p < .001). ConclusionsGastrointestinal symptoms decrease with increasing age in the first 7 months of life. The IGSQ has evidence of acceptable internal consistency reliability and concurrent validity. Practice implicationsThese data can be used to guide IGSQ score interpretation.

Symptoms of Gastroesophageal Reflux in Healthy, Full-Term Infants Younger Than 7 Months Old

ObjectiveTo describe the range of symptoms of gastroesophageal reflux in healthy, full-term infants in the first 7 months of life. DesignCross-sectional, descriptive study. Median and percentile scores for the Infant Gastroesophageal Reflux Questionnaire–Revised (I-GERQ-R) were calculated for each of the following age groups of infants: 0 to 2, 2 to 4, 4 to 6, and 6 to 7 months. Psychometric properties, including internal consistency reliability and concurrent validity of the I-GERQ-R, were also tested. SettingOnline. ParticipantsPrimary caregivers of 559 healthy, full-term (≥37 weeks gestational age) infants younger than 7 months. MeasurementsParticipants were asked to answer questions about themselves, their family, and their infant and to complete the I-GERQ-R, the Infant Gastrointestinal Symptoms Questionnaire, and the Neonatal Eating Assessment Tool. ResultsSymptoms of gastroesophageal reflux decreased over the first 7 months of life. Scores in the 95th percentile decreased from 19 in infants 0 to 2 months old to 16.7 in infants 6 to 7 months old. Internal consistency reliability of the I-GERQ-R was acceptable (Cronbach’s α = .71). The I-GERQ-R had evidence of concurrent validity with the Infant Gastrointestinal Symptoms Questionnaire (rs = .69, p < .001) and Neonatal Eating Assessment Tool–Breastfeeding Gastroesophageal Function subscale (rs = .52, p < .001). ConclusionsAuthors of prior studies used a cutoff score of 16 for the diagnosis of gastroesophageal reflux disease in infants younger than 18 months. Our results indicate that symptoms of reflux change with age over the first 7 months of life and that using more age-specific reference values may be more appropriate. Health care providers can use these age-specific percentile scores, together with clinical assessment, to identify significant symptomatology related to gastroesophageal reflux disease.

Real-world study in infants fed an infant formula with two human milk oligosaccharides

Introduction: human milk oligosaccharides (HMOs) are an important component of human milk supporting the development of a balanced intestinal microbiota and immune protection in breastfed infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. Participants and methods: this open-label, prospective study was conducted at six centers in Spain, and included healthy, exclusively breastfed infants (BF group), an exclusively formula-fed group (FF) who received a milk-based formula with 2' FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs). Results: 159 infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth were similar between all groups and within ± 0.5 of WHO medians at week 8. Composite IGSQ scores demonstrated low GI distress in all groups, with no significant group differences at baseline, week 4, or week 8. Incidence of AEs was low overall, and comparable across groups. Conclusions: in this RWE study examining a HMO-supplemented infant formula, growth and tolerance outcomes were similar to RCT findings, supporting the effectiveness of this early feeding option.

Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.

Background:Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high sn-2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance.Methods:In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days. Primary endpoint was daily duration of fussiness-crying. Secondary endpoints included gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety.Results:Mean ± SE minutes/day of fussiness-crying in the 256 analyzed infants (FA, n = 127 and FB, n = 129) substantially decreased from baseline to study end in FA (291 ± 14 to 140 ± 8; –52%, P < .001), and FB (313 ± 14 to 153 ± 11, –51%, P < .001) with no difference between groups. Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas. Mean ± SE IGSQ index scores significantly decreased from baseline to study end (FA: 44.5 ± 0.9 to 28.6 ± 0.7; FB: 44.5 ± 0.8 to 29.0 ± 0.7; P < .001) with no differences between groups. Infant temperament and maternal anxiety also improved significantly in both groups by study end.Conclusion:Switching from standard, full-lactose, intact whey/casein infant formulas to either study formula resulted in an improvement of gastrointestinal symptoms and associated behaviors in infants with signs of feeding intolerance.Trial Registration:https://clinicaltrials.gov, NCT02021058

Optimal nutrition in gastrointestinal distress among infants aged 6-8 weeks: An observational study in India

The ambiguity among the gastrointestinal (GI) disease symptoms and aetiology in apparently healthy, well-fed term infants make the diagnosis and interventions of GI disease challenging. We assessed if there was a difference in the GI tolerance of lactose predominant formula-fed and human-milk fed infants. The study divided mother and infant (68 weeks of age) pairs into predominantly breastfeeding (BF) and predominantly infant formula (IF) feeding groups. The Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) index score and symptom-wise (stooling, spitting/vomiting, crying, fussiness, and flatulence) analysis showed no statistically significant difference between the study groups. The role of optimal nutrition which is closer to breastmilk in providing gut comfort has been elicited by this study. 100% lactose-based formula can be considered as a promising alternative to the management of infants with GI distress, however, IF should always be considered as a substitute and not a replacement to breastmilk.

Use of a Partially Hydrolyzed 100% Whey-Based Infant Formula with Lactobacillus Reuteri in Infants with Caregiver-Perceived Intolerance

This study evaluated the impact of switching exclusively formula-fed infants with caregiver-perceived formula intolerance to a reduced lactose, partially hydrolyzed 100% whey-based formula (PHF-W) with Lactobacillus reuteri and 2-fucosyllactose. Infants identified as ‘very’ or ‘extremely’ fussy by caregivers were eligible for this single-arm, single-blind study. Subjects switched their current formula to study formula for three weeks. Gastrointestinal tolerance was assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) at baseline and end of the study. Caregivers ranked their infants’ fussiness (not at all, slightly, moderately, very, extremely) after the first three feedings of study formula and 24 hours after enrollment. A paired t-test was used to compare the change in IGSQ score, and a paired t-test and Wilcoxon signed rank test were used to compare post-feeding fussiness scores to baseline. Fifty infants (mean±std age 28.9±14.5 days) were enrolled; 41 completed the study per protocol. Mean (±std) baseline IGSQ score was 34.9±10.0, dropping to 22.1±7.5 after three weeks (p &lt; 0.001). 48/50 (96%) caregivers stated their infants’ fussiness improved after 24 hours, and 2 (4%) remained the same. 42/46 (91%) caregivers stated their infants’ fussiness improved after the first feeding, and 4 (9%) remained the same. Caregiver-ranked fussiness significantly improved after the first, second, and third feedings and after 24 hours as compared to baseline (p &lt; 0.001 for all). IGSQ scores significantly improved after three weeks of feeding with PHF-W containing Lactobacillus reuteri and 2-fucosyllactose in infants with caregiver-perceived intolerance, and improvements in fussiness were noted as quickly as after the first feeding.

Neonatal Eating Assessment Tool - Mixed Breastfeeding and Bottle-Feeding (NeoEAT - Mixed Feeding): factor analysis and psychometric properties

BackgroundEarly identification of feeding difficulty in infancy is critical to supporting breastfeeding and ensuring optimal nutrition for brain development. The Neonatal Eating Assessment Tool (NeoEAT) is a parent-report assessment that currently has two versions: NeoEAT – Breastfeeding and NeoEAT – Bottle-feeding for use in breast and bottle-fed infants, respectively. There are currently no valid and reliable parent-report measures to assess feeding through a combination of both breast and bottle delivery. The purpose of this study was to conduct a factor analysis and test the psychometric properties of a new measure, the NeoEAT – Mixed Breastfeeding and Bottle-Feeding (NeoEAT – Mixed Feeding), including internal consistency reliability, test-retest reliability, construct validity and known-groups validity.MethodsParents of infants younger than 7 months who had fed by both bottle and breast in the previous 7 days were invited to participate. Internal consistency reliability was tested using Cronbach’s α. Test-retest reliability was tested between scores on the NeoEAT – Mixed Feeding completed 2 weeks apart. Construct validity was tested using correlations between the NeoEAT – Mixed-Feeding, the Infant Gastroesophageal Reflux Questionnaire - Revised (I-GERQ-R), and the Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Known-groups validation was tested between healthy infants and infants with feeding problems.ResultsA total of 608 parents participated. Exploratory factor analysis revealed a 68-item scale with 5 sub-scales. Internal consistency reliability (Cronbach’s α = .88) and test-retest reliability (r = 0.91; p < .001) were both acceptable. Construct validity was demonstrated through correlations with the I-GERQ-R (r = 0.57; p < .001) and IGSQ (r = 0.5; p < .001). Infants with feeding problems scored significantly higher on the NeoEAT – Mixed Feeding, indicating more problematic feeding symptoms, than infants without feeding problems (p < .001), supporting known-groups validity.ConclusionsThe NeoEAT – Mixed Feeding is a 68-item parent-reported measure of breast- and bottle-feeding behavior for infants less than 7 months old that now has evidence of validity and reliability for use in clinical practice and research. The NeoEAT – Mixed Feeding can be used to identify infants with problematic feeding, guide referral decisions, and evaluate response to interventions.

Associations Between Health-related Quality of Life, Eating Behavior and Gastrointestinal Tolerance Among Exclusively Breastfed Infant-Mother Dyads in the Philippines (P11-107-19)

ObjectivesBreastmilk offers the most optimal nutrition for infants in first year of life, and breastfeeding may offer additional benefits promoting psychological well-being of infants and mothers. Relationships between infant and maternal quality of life (QoL), baby eating behaviors and gastrointestinal (GI) tolerance have not been widely studied. MethodsHealthy term infants whose mothers had decided to exclusively breastfeed from birth until 6 months (m) of age, were enrolled at 21–26 days (d) of age from a single center in the Philippines. Parents completed the Infant Toddler Quality of Life Questionnaire (ITQoL), Short Form Health Survey (SF-36v2) (assessing maternal QoL), Baby Eating Behavior Questionnaire (BEBQ) (assessing appetite), and Infant Gastrointestinal Symptoms Questionnaire (assessing GI burden) at enrollment and when infants were 2.5 m, 4 m, and 6 m of age. ResultsAmong 75 enrolled infants, 70 completed the study at age 6 m. At enrollment, only 1 statistically significant moderate correlation (ρ = 0.46, P < 0.01, Table 1) was seen between maternal Physical Health Summary with infant QoL Impact on Parents-Time. However, most infant QoL concepts became moderately associated with maternal Mental Health Summary scores at 6 m. Statistically significant moderate and positive correlations were detected between maternal Mental Health Summary with Satisfaction with Child’s Overall Growth and Development, Temperament and Moods, Overall Health, and with 3 Child’s Impacts on Parents concepts. At 6 m, statistically significant moderate and positive correlations were seen between BEBQ concepts (Enjoyment of Food and General Appetite) with Temperament and Moods (ρ = 0.47 and 0.40, respectively, P < 0.01). No moderate correlations between BEBQ concepts and maternal QoL were found. Surprisingly, no correlations between GI tolerance measures and maternal/infant QoL concepts was detected except 1 weak correlation between flatulence and infant QoL Impact on Parents-Emotional at enrollment. ConclusionsIn this cohort, relationships between infant and maternal health-related quality of life evolved as infants grew older. Infant temperament and moods positively correlated with both maternal mental and physical health and with infant eating behaviors, suggesting that infant temperament and mood may be an important factor affecting maternal and child health. Funding SourcesNestec Ltd. Supporting Tables, Images and/or Graphs▪

Health-Related Quality of Life in Exclusively Breastfed Filipino Mother-Infant Dyads (P11-059-19)

ObjectivesHealth-related quality of life (QoL) is an important component of overall wellbeing. The study aimed to describe the parent-perceived infant quality of life of exclusively breastfed infants along with their mother’s physical and mental health in a Filipino cohort. MethodsHealthy term infants, who were exclusively breastfed since birth and whose mothers had decided to exclusively breastfeed until 6 months (m) of age, were enrolled at 21–26 days of age from a single center in the Philippines. Parents completed the Infant Toddler Quality of Life Questionnaire (ITQoL) and the Short Form Health Survey (SF-36v2) (assessing maternal QoL) at enrollment and when infants were 2.5 m, 4 m, and 6 m of age. Infants’ anthropometrics were measured and parents completed gastrointestinal (GI) diaries and Infant Gastrointestinal Symptoms Questionnaire (IGSQ) throughout the study. ResultsAmong 75 enrolled infants, 70 completed the study at age 6 m. Infant QoL mean scores were high throughout the study (range 0–100 for each concept; Table 1). Nonetheless, noticeable improvements were observed between enrollment and 2.5 m, especially in the infant-focused concept of Temperament and Moods as well as in all three parent-focused concepts (Emotional, Time, and Family Cohesion) which measure impact of child’s health on parents. Between 2.5 and 6 m, the scores remained relatively stable. For maternal QoL mean scores (scores standardized to Mean = 50, SD = 10 for each scale; Table 1), noticeable improvements were observed between enrollment and 2.5 m, with Physical Health showing more pronounced improvements. The Role-Emotional scale, which measures role limitations due to emotional problems, showed the lowest scores. From enrollment to age 6 m, mean z-scores for weight-for-age, length-for-age and head circumference-for-age stably tracked WHO Growth Standards. Additionally, infant stool consistency became more formed, and incidences of spitting up/vomiting and flatulence decreased. The overall GI burden also decreased (IGSQ index score: range 13–65; 15.8 ± 3.2 at enrollment and 14.0 ± 1.2 at 6 m). ConclusionsIn a cohort of exclusively breastfed Filipino mother-infant dyads, parent-perceived infant health-related quality of life was high and comparable to that reported in literature1. Maternal quality of life, particularly their perceived state of emotional well-being, warrants further investigation. Funding SourcesNestec Ltd. Supporting Tables, Images and/or Graphs▪