Gastrointestinal Symptoms In Adults Research Articles

Healthcare Burden in Greenland of Gastrointestinal Symptoms in Adults with Inherited Loss of Sucrase-Isomaltase Function.

Congenital sucrase isomaltase deficiency (CSID) is in general a very rare disease. However, 2-3% of the Greenlandic population are homozygous (HO) carriers of an Arctic-specific loss-of-function (LoF) variant in the sucrase-isomaltase (SI) encoding gene, causing CSID. The condition is characterized by gastrointestinal symptoms such as stomachache, diarrhea, and weight loss when consuming sucrose, the most common dietary sugar. However, the awareness of the condition in the population and the healthcare system seems to be limited, potentially leading to a higher healthcare burden. Hence, we aimed to investigate whether HO-carriers visit the healthcare system more with gastrointestinal symptoms compared to the control groups by using registry data. We performed a case-control study identifying cases and controls using genotype information from the 1999-2001 and 2005-2010 Greenlandic health population cohorts. The cases were defined as HO LoF SI-carriers and controls were defined as non-carriers and were matched (1:1) on sex, age, place of residence, and European genetic admixture. We used electronic medical records to assess the number of electronic medical record contacts (EMRc) related to gastrointestinal symptoms and the number of gastrointestinal-related diagnostic procedures. A total of 80 HO-carriers and 80 non-carriers were included. The HO-carriers had 19% more EMRc related to gastrointestinal symptoms (IRR, 1.19, 95% CI [1.02;1.40], p=0.02) and had a 41% higher incidence of gastrointestinal related diagnostic procedures compared to controls (IRR, 1.41, 95% CI [1.05-1.92], p=0.02). Only one HO-carrier was aware of the condition according to the electronic medical records. HO-carriers of the LoF SI-variant had both significantly more gastrointestinal-related EMRc and significantly more diagnostic procedures conducted due to gastrointestinal symptoms. Only one HO-carrier was aware of the condition. Given the high prevalence of HO-carriers in the Greenlandic population, we anticipate that diagnosing more patients with CSID and providing dietary advice could potentially reduce symptom burden and healthcare visits among HO-carriers.

Donor-recipient specificity and age-dependency in fecal microbiota therapy and probiotic resolution of gastrointestinal symptoms

Fecal microbiota transplantation (FMT) has proven to be an effective treatment for recurrent Clostridioides difficile infection (rCDI) in both adult and pediatric patients. However, as microbiome development is a critical factor in children, it remains unclear whether adult fecal donors can provide age-appropriate functional restoration in pediatric patients. To address this issue, we conducted an integrated systems approach and found that concordant donor strain engraftment, along with metabolite restoration, are associated with FMT outcomes in both adult and pediatric rCDI patients. Although functional restoration after FMT is not strain-specific, specialized metabolic functions are retained in pediatric patients when adult fecal donors are used. Furthermore, we demonstrated broad utility of high-resolution variant-calling by linking probiotic-strain engraftment with improved gastrointestinal symptoms in adults with irritable bowel syndrome and in children with autism spectrum disorder. Our findings emphasize the importance of strain-level identification when assessing the efficacy of probiotics and microbiota-based therapeutics.

Efficacy of a prebiotic formulation for treatment of functional constipation and associated gastrointestinal symptoms in adults: A randomised controlled trial

ObjectivesFunctional constipation is the result of a complex interplay between the gastrointestinal tract, the gut microbiome, the nervous system, along with diet and lifestyle factors. This study aimed to evaluate the efficacy of a prebiotic formulation containing plant-based extracts rich in dietary fibre and polyphenols in the management of functional constipation and associated gastrointestinal symptoms. DesignThis 3-week randomised controlled study assessed the effect of a prebiotic formulation (6 g powder taken in water twice daily), by comparison with a capsule designed to have minimal effect on gastrointestinal function, on indicators of bowel health in healthy adults with low fibre intake and meeting the Rome IV criteria for functional constipation. MethodsParticipants were informed that they may receive one of two products, either a powder or a capsule, both of which contained prebiotics. The primary outcome was change in frequency of complete spontaneous bowel movements. Secondary outcomes assessed were gastrointestinal symptoms, quality of life and mood using the PAC-SYM, PAC-QoL, and DASS-21. Safety and tolerability were also assessed. ResultsThere was a significant improvement in bowel movements (p < 0.001) and improved stool consistency (p < 0.01) in participants taking the prebiotic powder formulation compared to those taking the capsule. Accompanying this was a significant reduction in overall gastrointestinal symptoms (p < 0.001) including abdominal (p < 0.001), rectal (p = 0.004) and stool (p = 0.002) symptoms, and a significant improvement in quality of life (p 0.001). There was a significant reduction in mean score for depression, anxiety, and stress for participants in both groups, which indicated a significant improvement in mood during the study that was unrelated to bowel function. ConclusionsThe results showed that the prebiotic powder formulation taken twice per day for 21 days was effective in reducing clinical symptoms of functional constipation in individuals reporting a low fibre intake.

The effects of Bacillus coagulans MTCC 5856 on functional gas and bloating in adults: A randomized, double-blind, placebo-controlled study.

Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. Bacillus coagulans MTCC 5856 (LactoSpore) is a spore-forming, thermostable, lactic acid-producing probiotic that has numerous health benefits. We evaluated the effect of Lacto Spore on improving the clinical symptoms of functional gas and bloating in healthy adults. Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive B coagulans MTCC 5856 (2 billion spores/day, N = 35) or placebo (N = 35) for 4 weeks. Changes in the GSRS-Indigestion subscale score for gas and bloating and global evaluation of patient's scores from screening to the final visit were the primary outcomes. The secondary outcomes were Bristol stool analysis, brain fog questionnaire, changes in other GSRS subscales, and safety. Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly (P < .001) in the probiotic group (8.91-3.06; P < .001) compared to the placebo (9.42-8.43; P = .11). The median global evaluation of patient's scores was significantly better (P < .001) in the probiotic group (3.0-9.0) than in the placebo group (3.0-4.0) at the end of the study. The cumulative GSRS score, excluding the indigestion subscale, decreased from 27.82 to 4.42% (P < .001) in the probiotic group and 29.12 to 19.33% (P < .001) in the placebo group. The Bristol stool type improved to normal in both the groups. No adverse events or significant changes were observed in clinical parameters throughout the trial period. Bacillus coagulans MTCC 5856 may be a potential supplement to reduce gastrointestinal symptoms in adults with abdominal gas and distension.

Psychological, behavioural and biological factors associated with gastrointestinal symptoms in autistic adults and adults with autistic traits.

Little is known about factors related to the increased risk for gastrointestinal symptoms in adults with an autism spectrum disorder (ASD), while the negative impact of gastrointestinal symptoms is evident. Especially, the relationship between gastrointestinal symptoms and psychological, behavioural, and biological risk factors in adults with ASD (traits) is unclear. Autistic peer support workers and autism-advocates also emphasised the importance of identifying risk factors, because of the high prevalence of gastrointestinal problems in people with ASD. Therefore, our study investigated which psychological, behavioural, and biological factors are associated with gastrointestinal symptoms in adults with ASD or with autistic traits. We analysed data from 31,185 adults in the Dutch Lifelines Study. Questionnaires were used to evaluate the presence of an autism spectrum disorder diagnosis, autistic traits, gastrointestinal symptoms, psychological and behavioural factors. Biological factors were examined with body measurements. We found that not only adults with ASD but also adults with higher levels of autistic traits were at increased risk for gastrointestinal symptoms. Adults with ASD who experienced psychological problems (psychiatric problems, worse perceived health, chronic stress) had a higher risk for gastrointestinal symptoms than adults with ASD without these psychological problems. Moreover, adults with higher levels of autistic traits were less physically active, which was also associated with gastrointestinal symptoms. In conclusion, our study highlights the relevance of identifying psychological problems and evaluating physical activity when trying to help adults with ASD or autistic traits and gastrointestinal symptoms. This suggests that healthcare professionals should be more aware of behavioural and psychological risk factors when evaluating gastrointestinal symptoms in adults with ASD (traits).

Diabetes is associated with increased burden of gastrointestinal symptoms in adults with cystic fibrosis

BackgroundIndividuals with diabetes mellitus (DM) are known to frequently experience gastrointestinal (GI) symptoms. In contrast, the impact of cystic fibrosis-related diabetes (CFRD) on accentuating GI symptoms in people with cystic fibrosis (pwCF) is unknown. We sought to examine this. MethodsAbdominal symptoms were measured using the validated CF-specific GI symptom questionnaire - CFAbd-Score© - as part of a multicentre cohort study in pancreatic insufficient adults with CF, not on cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The CFAbd-Score total score (0–100pts), its 5 domains, alongside nine specific GI symptoms associated with DM, were compared between the CFRD and non-CFRD groups. Results27 (31%) and 61 (69%) participants with CF were recruited in the CFRD and non-CFRD groups respectively. Total CFAbd-Score and the two domains: gastroesophageal reflux disease and disorders of appetite were significantly higher in the CFRD group compared to the non-CFRD group (p<0.05), with the mean total CFAbd-Score being 25.4 ± 2.5 and 18.4 ± 1.5 in the CFRD and non-CFRD groups respectively. Among the nine GI symptoms commonly reported as elevated in DM, bloating and nausea were significantly more common in individuals with CFRD compared to those without (p<0.05). ConclusionsIndividuals with CFRD overall, have a higher GI symptom burden, according to CFAbd-Scores. Specifically, they experience significantly more bloating and nausea. Close monitoring and further research is needed to better understand and manage GI symptoms in this group.

Congenital diaphragmatic hernia in adults: a decade of experience from a single tertiary center

Introduction Congenital diaphragmatic hernias (CDHs) in adults remain rare, with limited data on them available. However, CDHs can cause respiratory and gastrointestinal symptoms in adults, even resulting in the strangulation of the bowel when incarcerated. Here, we aimed to analyze surgical outcomes among adult patients. The primary outcome of interest was the complication rate, reoperations and 90-day mortality after laparoscopic and open hernia repair. Methods We identified all adult patients diagnosed with a Morgagni or Bochdalek hernia treated operatively between 2010 and 2019 in a single tertiary care hospital. Data on patient demographics, surgical characteristics, mortality and morbidity were collected. Results In total, we identified 37 patients (67.6% female; average age, 57 years). Overall, 78.4% patients underwent minimally invasive operations, while 35.1% underwent emergency operations. A Clavien–Dindo grade II–V complication was experienced by 18.9% of patients. No deaths occurred within 90 days of surgery, and we detected no recurrences in short-term or long-term follow-up. A minimally invasive technique correlated with a shorter hospital stay of 3.6 days versus 6.8 days in the open surgery group (p = .007, t = 3.3, 95% confidence interval = 1.04−5.21). Conclusion Our findings indicate that the laparoscopic repair of a congenital diaphragmatic hernia is safe and effective, offering short hospital stay and a low amount of complications.

P167 Pancreatic enzyme replacement therapy intake and gastrointestinal symptoms in adults with cystic fibrosis: a cross-sectional study in Copenhagen, Denmark

P167 Pancreatic enzyme replacement therapy intake and gastrointestinal symptoms in adults with cystic fibrosis: a cross-sectional study in Copenhagen, Denmark

Patient-reported prevalence of gastrointestinal issues in the adult skeletal dysplasia population with a concentration on osteogenesis imperfecta.

Patient-reported concerns indicate that gastrointestinal (GI) manifestations affect the skeletal dysplasia population, but quantitative information regarding prevalence and severity of GI issues is limited. We examined the frequency and characteristics of GI symptoms in adults with skeletal dysplasias by reviewing 101 responses to the Gastrointestinal Symptom Rating Scale (GSRS). Participant demographics, medication history, and ambulatory status were collected from medical records. Compared to published GSRS reference data, our cohort scored higher on reflux, diarrhea, and total scores, and lower on abdominal pain and indigestion scores; none of these differences were statistically significant. Although osteogenesis imperfecta respondents had more severe symptoms across all domains, only reflux reached significance (p=0.009). Scores in patients with achondroplasia were higher for indigestion, constipation, diarrhea, and total scores and lower on abdominal pain and reflux scores than the general population; only the diarrhea score was significant (p=0.034). There were no statistically significant differences in any of the domain or total GSRS scores across ambulatory status groups. Increased height correlated with worse abdominal pain domain score (p=0.033). The number of medications positively correlated with total GSRS score (p=0.013). Future studies should include larger numbers of individuals to allow a more in-depth analysis of patient-reported symptoms and signs within this population.

S904 Gastrointestinal Symptoms in Patients With Inflammatory Bowel Disease After SARS-CoV-2 mRNA Vaccination

Introduction: In the SARS-CoV2 mRNA vaccine trials, post-vaccination gastrointestinal (GI) symptoms were reported in 10-20% of participants. These symptoms could be perceived as inflammatory bowel disease (IBD) flare which could lead to patient anxiety, and unnecessary tests or treatment. We aimed to assess GI symptoms after SARS-CoV2 mRNA vaccination in patients with IBD relative to non-IBD healthcare workers (HCW). Methods: We assessed GI symptoms in adults with IBD and HCW at baseline and after each dose of a SARS-CoV-2 mRNA vaccine. We analyzed patient-reported IBD-specific disease activity (PRO2) after each dose (stool frequency (SF) and rectal bleeding for ulcerative colitis (UC), SF and abdominal pain for Crohn's disease (CD)). We also compared the frequency, severity, and duration of postvaccination GI symptoms in IBD patients compared to HCW. Severity was defined by impact on daily activities (mild, did not interfere;moderate, some interference;severe, prevented routine activity;extreme, required hospitalization). Severe and extreme were combined and designated as severe+. Duration was classified as 7 days. Results: Post-vaccination GI symptoms were assessed after dose 1 (D1) (1391 IBD, 933 HCW) and dose 2 (D2) (1271 IBD, 884 HCW) (Table). About 60% of IBD and>99% of HCW received the BNT162b vaccine (Pfizer);the remainder received mRNA-1273 (Moderna). New GI symptoms after D1 were more frequent among IBD than HCW (6.0% vs 2.9%, p=0.001) but not after D2 (12.1% vs 12.7%, p=NS). Relative to HCW, IBD patients reported more diarrhea (3.8% vs. 1% (p<0.001) after D1 and 7.5% vs 4.2% (p=0.003) after D2) and abdominal pain (2.2% vs. 0.4% (p=0.001) after D1 and 6.2% vs 3% (p=0.002) after D2). Severe1 symptoms were noted in 1.5% IBD and 0.3% HCW (p=NS) after D1 and in 3.3% IBD and 0.1% HCW (p<0.001) after D2 (Figure 1). Longer GI symptom duration was more common in IBD than HCW after D1 (2.1% vs 0.5%, p=0.002) and D2 (5.4% vs. 2.1%, p<0.001). Among 423 CD and 300 UC patients with PRO2 data, 71%, 68%, and 65% of CD and 86%, 86%, and 83% of UC were in clinical remission at baseline, after D1, and after D2, respectively. Conclusion: The frequency of GI symptoms in IBD was greater than HCW after D1, but similar after D2. More severe and longer duration of GI symptoms were noted in a small number of IBD patients. Reassuringly, the mRNA vaccines do not seem to increase the risk of a disease flare in the vast majority of IBD patients.

Inter-individual Variability in Gut Microbiota Composition Is Associated With Changes in the Fecal Metabolome of Individuals Consuming a Military Ration Diet

ObjectivesThe fecal metabolome provides a functional readout of interactions between host, diet and the gut microbiota that may help identify gut microbiota-derived compounds associated with health outcomes. This study aimed to determine associations between inter-individual variability in gut microbiota composition, diet-induced changes in the fecal metabolome and gastrointestinal symptoms in adults consuming a diet consisting solely of military rations. MethodsSecondary analysis of a randomized-controlled trial in which 54 healthy adults (32 ± 14 yr, BMI 26 ± 3 kg/m2) were randomly assigned to consume their usual diet (Control) or a provided diet of Meal, Ready-to-Eat military rations (MRE) for 3wk. Fecal microbiota composition was measured by 16S rRNA sequencing and the fecal metabolome by untargeted UPLC-MS/MS at baseline and post-intervention. Self-reported gastrointestinal symptoms were measured weekly using the Irritable Bowel Severity Scoring System (IBSSS). ResultsPrincipal coordinates analysis of baseline gut microbiota composition separated MRE participants into two clusters determined primarily by ratio of Bacteroides to Prevotella (HIGH (n = 17) or LOW (n = 10)). Random Forest classification of changes in the fecal metabolome within Control, HIGH, and LOW produced error rates of 7%, 18% and 100%, respectively, suggesting a more discriminant metabolome response in HIGH than LOW. Between-group differences in 153 metabolites were detected by ANOVA (FDR <0.20). Among those, 39 identified and 20 unidentified metabolites demonstrated an association with the gut microbiota (HIGH vs. LOW, P < 0.05). Compounds within xenobiotic, peptide/amino acid, and lipid metabolism pathways comprised 29 of the microbiota-associated metabolites. Changes in microbiota-associated metabolites were not correlated with changes in IBSSS scores. ConclusionsChanges in the fecal metabolome of individuals consuming a short-term military ration diet are associated with inter-individual variability in gut microbiota composition, but changes in microbiota-associated fecal metabolites do not appear to impact gastrointestinal symptoms. Funding SourcesMilitary Operational Medicine Research Program. DisclaimerAuthors’ views do not reflect official DoD or Army policy.

The Effect of Gum Arabic (Acacia Senegal) on Cardiovascular Risk Factors and Gastrointestinal Symptoms in Adults at Risk of Metabolic Syndrome: A Randomized Clinical Trial.

Gum Arabic (GA) is a widely-used additive in food processing, but is also historically used in a number of traditional therapies. It has been shown to have a broad range of health benefits, particularly in improving important cardiovascular risk indicators. Metabolic syndrome and its associated cardiac outcomes are a significant burden on modern healthcare systems, and complementary interventions to aid in its management are required. We aimed to examine the effect of GA on those with, or at risk of, metabolic syndrome to identify an effect on improving important disease parameters related to cardiovascular outcomes. A single-blind, randomized, placebo-controlled trial was conducted to identify the effects of daily GA supplementation on metabolic and cardiovascular risk factors. A total of 80 participants were randomized to receive 20 g of GA daily (n = 40) or placebo (1 g pectin, n = 40) for 12 weeks. Key endpoints included body-anthropometric indices, diet and physical activity assessment, and blood chemistry (HbA1c, fasting glucose, and blood lipids). Of the 80 enrolled, 61 completed the study (intervention: 31, control: 30) with 19 dropping out due to poor treatment compliance. After 12 weeks, the participants receiving the GA showed significant decreases in systolic and diastolic blood pressure, fat-free body mass, energy and carbohydrate consumption, and fasting plasma glucose, as well as increased intake of dietary fiber. They also reported improvements in self-perceived bloating and quality of bowel movements, as well as a decreased appetite score following GA consumption. These results suggest that GA could be a safe and beneficial adjunct to other treatments for those with, or at risk of, metabolic syndrome.

Prevalence and Determinants of Gastrointestinal Symptoms in Adults on Maintenance Hemodialysis in Cameroon

Introduction: Gastrointestinal symptoms (GIS) are common in patients on maintenance hemodialysis and constitute an important cause of morbidity. Objectives: To determine the prevalence of GIS and identify their determinants in adults on maintenance hemodialysis in Cameroon. Patients and Methods: This hospital-based cross-sectional study was conducted from January to May 2017 at the Yaounde University Teaching Hospital dialysis center. All conscious consenting adults’ patients who provided a written informed consent and have been on hemodialysis for more than three months with an arterio-venous fistula were recruited. All chronic hemodialysis patients of the center dialyze 4 hours twice a week. All patients with dementia were excluded. We collected demographic, clinical, and paraclinical data and used Rome IV modified GIS rating scale. Parametric and non-parametric tests were used to compare variables. Results: We included 83 (72.3% males) participants with a mean (SD) age of 50 (12) years. Hypertension (31.3%), chronic glomerulonephritis (26.5%) and diabetes mellitus (20.5%) were the leading baseline nephropathy. There were 31 (37.3%) participants with psychiatric disorders including anxiety (45.2%) and depression (54.8%). The biological abnormalities were increased parathormone (20.5%), hypocalcemia (24.1%), hyperphosphatemia (32.5%), increased C-reactive protein (46.4%) and anemia (68.7%). The GIS was reported in 73 (87.9%) participants. Diarrhea (47%), constipation (38.6%), vomiting (38.6%), anorexia (33.7%) and nausea (31.3%) were the main GIS observed. The presence of hypertension was the only association with the GIS (p = 0.02). We did not find any association between GIS and age, gender, diabetes mellitus, psychiatric disorders and duration in dialysis (all p > 0.1). Conclusion: We reported a high prevalence of GIS in this mainly young adult population. This could be related to their under-dialysis status and suggest the increased frequency of dialysis session in this setting.

A high prevalence of chronic gastrointestinal symptoms in adults with cystic fibrosis is detected using tools already validated in other GI disorders.

People with cystic fibrosis (CF) report a variety of gastrointestinal (GI) symptoms, independent of pancreatic enzyme insufficiency (PEI), reminiscent of other chronic GI disorders. There are currently no accepted or validated assessment tools and neither the range, frequency nor severity of GI symptoms has been systematically described in CF. We present results of a cross-sectional study using established tools and compare them to current measures of quality of life (QOL). Consecutive patients attending specialist CF appointments were asked to complete questionnaires including the GI Symptom Rating Scale (GSRS); Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and Cystic Fibrosis Questionnaire (CFQ-R). Questionnaire terminology was altered to replace references to 'IBS' with 'GI symptoms'. In total, 107 patients were recruited (mean age, 27.8 ± 9.6 years; 60 female), and 94 (88%) had PEI. Body mass index was 22.1 ± 3.6 kg/m2, forced expiratory volume in one second was 59 + 27.7% predicted. Fifty-three (49.5%) were p.Phe508del homozygous. Overall 69/107 (65%) reported significant GI symptoms independent of PEI or adherence to pancreatic enzyme replacement therapy (PERT), with the four most frequent being attributable to the lower GI tract: bloating/distension, flatulence, abdominal pain and borborygmi (gurgling). There was no numerical correlation between any CFQ-R domain (particularly Digestion domain) and GSRS or SSS. This is the first systematic study measuring GI symptoms in CF using validated GI tools. Symptoms are not related to PERT or genotype and appear to be captured well by the GSRS. Further research will study longitudinal changes with treatment, and therapeutic trials in CF may use these tools to demonstrate a positive impact on 'non-respiratory' symptoms and QOL.

Efficacy of Polydextrose Supplementation on Colonic Transit Time, Bowel Movements, and Gastrointestinal Symptoms in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.

The addition of fiber is one of the most important dietary means to relieve constipation through lifestyle modification. Polydextrose (PDX) has been reported in several studies to increase fecal bulk, soften stools, and increase the number of defecations. However, there are few studies on the effect of PDX on colonic transit time (CTT). Therefore, the aim of this study was to demonstrate the effect of PDX on CTT and other aspects of gastrointestinal function during two weeks (Day 1 to Day 14), preceded by a 2-week run-in period (Day -14 to Day -1). A total of 192 adults who were diagnosed with functional constipation per Rome III criteria were recruited for the study. Participants were randomized equally into 4 groups (12 g, 8 g, or 4 g of PDX or placebo per day). The primary endpoint was CTT, assessed using radio-opaque markers and abdominal X-rays on Day 0, the baseline; and Day 15, the end of the intervention. Secondary outcomes that were measured using inventories were the patient assessment of constipation symptoms and quality of life, bowel function index, relief of constipation, bowel movement frequency (BMF), stool consistency, degree of straining, and proportion of bowel movements. Ancillary parameters and harms were also evaluated. The recruited population was not sufficiently constipated (e.g., baseline values for CTT and BMF of 42 h and 8.7 BMF/week, respectively). Despite this limitation, our results demonstrated an increased number of bowel movements when supplemented with PDX at a dosage of 12 g per day for 2 weeks. This dosage also consistently improved the secondary outcomes that were measured using inventories at Day 15, compared with the baseline. No serious or significant adverse events were reported during the study.

Effect of a prebiotic galactooligosaccharide mixture (B-GOS®) on gastrointestinal symptoms in adults selected from a general population who suffer with bloating, abdominal pain, or flatulence.

Prebiotics exert beneficial effects upon gastrointestinal (GI) environment, but this is not always accompanied with a positive effect on GI symptoms. B-GOS® is a prebiotic with high selectivity toward bifidobacteria and a variety of other beneficial effects in humans. Here, we investigated its effect on GI symptoms in adults who suffer with bloating, abdominal pain, and flatulence. In a double-blind, placebo-controlled, crossover study, 83 subjects from the general population who presented with GI symptoms during screening period and had a predicted probability of functional bowel disorder of more than 75% were randomized to receive either a placebo or the B-GOS® treatment (2.75g/d). Subjects were screened for the presence of GI symptoms for 1 week, they consumed the treatments for 2 weeks, and then went through a 2-week washout period, before switching to the other treatment for the final 2 weeks. GI symptoms, bowel movements, and stool consistency were assessed in daily and weekly questionnaires. Quality of life was assessed weekly and depression and anxiety at the end of each treatment period. B-GOS® resulted in significantly (P<0.001) lower scores for bloating, flatulence, and abdominal pain both from baseline and placebo at the end of first week. The effect was sustained at the end of second week. It had no effect on the number of bowel movements, consistency of stools, quality of life, or mood throughout the study. Results suggest that B-GOS® could possibly be used in the management of bloating, flatulence, or abdominal pain and warrant further investigation.

Frequency, Severity, and Associations of Gastrointestinal Symptoms in Adults and Children with Type 1 Diabetes

Background: Significant variability is reported as to the presence and quality of gastrointestinal (GI) symptoms in patients with type 1 diabetes (T1D). Objective: To assess reported GI symptoms and associated comorbidities in adults and children with T1D. Methods: The Gastrointestinal Symptom Scale (GISS) and a Visual Analog Scale (VAS) were used to assess GI symptom type and severity in 2,370 patients with T1D aged 8-45 years as part the screening phase of the Celiac Disease and Diabetes Dietary Intervention and Evaluation Trial (CD-DIET). Co-morbidities, including diabetes-related complications, were extracted from clinical records. The presence and severity of GI symptoms and relationships with demographic, clinical and other diabetes-related factors were evaluated. Results: Overall, 1368 adults (57.7%) aged 19-45 years and 1002 (42.3%) pediatric patients aged 8-18 years were studied. At least one GI symptom was reported in 34.1% of adults as compared with 21.7% of children (p&amp;lt;0.0001). Common symptoms in children included upper abdominal pain, lower abdominal pain and nausea while adults more frequently reported lower GI symptoms with females describing more severe symptoms. Overall, patients with ≥1 GI symptom were more likely to have diabetes complications when adjusted for age and sex (OR=1.41; 95% CI=1.1-1.7; p=0.002). Conversely, patients who reported diabetes complications such as nephropathy, retinopathy and/or cardiovascular disease were 1.94 (95% CI=1.49-2.52) times more likely to report GI symptoms. No association was observed between autoimmune conditions (including screen-detected celiac disease and reported thyroid disease) and GI symptoms. Conclusions: In this large screening study in a contemporary T1D cohort, significant differences were found between age groups with more frequent GI symptoms in adults. Significant associations were observed between GI symptoms and diabetes complications along with diabetes duration. Disclosure F.H. Mahmud: None. E. Nunes de Melo: None. A.B. Clarke: None. E. Assor: None. A. Parikh: None. A. Advani: Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH. Other Relationship; Self; Boehringer Ingelheim GmbH. B.A. Perkins: Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH, Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Abbott. Speaker's Bureau; Self; Abbott, Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Insulet Corporation. Speaker's Bureau; Self; Insulet Corporation, Dexcom, Inc.. B.R. Shah: None. C.S. Zuijdwijk: None. C. McDonald: None. D. Mack: None. D. Koltin: None. E. Hsieh: None. E.M. Szentgyorgyi: None. F. Saibil: None. G. Mukerji: None. H.A. Lochnan: Research Support; Self; Amylin Pharmaceuticals, Boston Therapeutics, Inc., Sanofi. J. Gilbert: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck &amp; Co., Inc., Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi. K. Bax: None. M.L. Lawson: None. M.D. Beaton: Advisory Panel; Self; Takeda Canada Inc., Janssen Pharmaceuticals, Inc., AbbVie Inc.. N.A. Saloojee: None. O. Lou: None. P.H. Gallego: None. R.L. Houlden: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., AstraZeneca, Eli Lilly and Company. R. Aronson: Other Relationship; Self; Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi, AstraZeneca. Research Support; Self; Eli Lilly and Company, Becton, Dickinson and Company, Merck &amp; Co., Inc., Senseonics, Boehringer Ingelheim Pharmaceuticals, Inc.. S.E. Kirsch: None. W.G. Paterson: None. Z. Punthakee: Research Support; Self; Amgen, Astra Zeneca/Bristol Myers Squibb, Lexicon, Merck, NovoNordisk, Sanofi. Speaker's Bureau; Self; Abbott, Astra Zeneca/Bristol Myers Squibb, Boehringer Ingelheim/Eli Lilly, Janssen, Merck, NovoNordisk, Pfizer, Sanofi. Advisory Panel; Self; Astra Zeneca/Bristol Myers Squibb, Boehringer Ingelheim/Eli Lilly, Dexcom, Janssen, Medtronic, NovoNordisk, Pfizer, Sanofi. M.A. Marcon: None.

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader\u2013Willi syndrome: study protocol for a randomized controlled trial

BackgroundConstipation is a frequent problem in adults with Prader–Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader–Willi syndrome.MethodsAdults with Prader–Willi syndrome (18–75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses.DiscussionTo our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader–Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation.Trial registrationClinicalTrials.gov (NCT03277157). Registered on 08 September 2017.

Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial

ABSTRACTBifidobacterium animalis subsp. lactis HN019 (HN019) ameliorates chronic idiopathic constipation. Our aim was to determine the efficacy and safety of 28-day supplementation with 1 × 109 or 1 × 1010 CFU of HN019/day for constipation. A total of 228 adults who were diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind and placebo-controlled trial. Colonic transit time (CTT), the primary outcome, and secondary outcomes that were measured using inventories—patient assessment of constipation symptoms (PAC-SYM) and quality of life (PAC-QoL), bowel function index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity—were assessed. Ancillary parameters and harms were also evaluated.There were no statistically significant differences in the primary or secondary outcomes between interventions. A post hoc analysis of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week) showed a physiologically relevant increase in weekly BMF in the high- (+2.0) and low-dose (+1.7) HN019 groups—by RMANOVA, the HN019 groups with BMF ≤ 3/week, pooled together, had a higher BMF versus placebo (P value = 0.01). Thus, improving low stool frequency could be a target of future interventions with HN019. High-dose HN019 also decreased the degree of straining at Day 28 versus placebo in those with BMF ≤ 3/week (P value = 0.02). Three unlikely related AEs—2 with low-dose HN019 and 1 with placebo—were followed until full recovery. In conclusion, although there were no differences in the primary analysis, HN019 is well tolerated and improves BMF in adults with low stool frequency.

Effects of 28-Day Bifidobacterium animalis subsp. lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation

Introduction:Bifidobacterium animalis subsp. lactis HN019 (HN019) reduces colonic transit time (CTT). Our aim was to study the efficacy and safety of 28-day supplementation with 1x109 or 1x1010 CFU of HN019/day for constipation. Methods: 228 adults diagnosed with functional constipation according to Rome III criteria were randomized in a double-blind and placebo-controlled trial. CTT, the primary outcome, and other outcomes measured using inventories— Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QoL), Bowel Function Index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity— were assessed. Ancillary parameters and harms were also evaluated. Results: All treatments, including placebo, ameliorated constipation after 28 days. There were no differences between treatments, except for a reduction in PAC-SYM Rectal Symptom Score with the placebo versus the high dose of HN019 at Day 28, possibly due to an artifact. The use of Rome III as the sole criterion for inclusion created discrepancies with the information from the inventories. By post hoc RMANOVA of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week), the HN019 groups, pooled together, experienced greater BMF versus placebo (P value=0.01). Highdose HN019 also decreased degree of straining at Day 28 versus placebo in those with BMF ≤ 3/week (P value=0.02). Three unlikely related AEs—2 with low-dose HN019 and 1 with placebo—were followed until a full recovery. Conclusion: Rome III classification, as the sole criterion for inclusion in clinical research, creates discrepancies in the diagnosis. In conclusion, HN019 is well tolerated and improves BMF in adults with low stool frequency.