Pediatric Functional Constipation Research Articles

Efficacy and acceptability of different probiotic products plus laxatives for pediatric functional constipation: a network meta-analysis of randomized controlled trials.

The prevalence of pediatric constipation ranges from 0.7 to 29.6% across different countries. Functional constipation accounts for 95% of pediatric constipation, and the efficacy of pharmacotherapy is limited, with a success rate of 60%. Several randomized controlled trials (RCTs) have shown the benefits of probiotic supplements in treating this condition. However, the reported strains of probiotics varied among the RCTs. We aimed to compare the efficacy and acceptability of different probiotic supplements for pediatric functional constipation. The current frequentist model-based network meta-analysis (NMA) included RCTs of probiotic supplements for functional constipation in children. The primary outcome was changes in bowel movement or stool frequency; acceptability outcome was all-cause discontinuation. Nine RCTs were included (N = 710; mean age = 5.5 years; 49.4% girls). Most probiotic products, used either alone or combined with laxatives, were associated with significantly better improvement in bowel movement or stool frequency than placebo/control. Protexin plus laxatives (standardized mean difference (SMD) = 1.87, 95% confidence interval (95% CI) = 0.85 to 2.90) were associated with the greatest improvement in bowel movement or stool frequency among all the investigated probiotic products. For the single probiotic interventions, only Lactobacillus casei rhamnosus Lcr35 was associated with significant efficacy compared to placebo/control treatments (SMD = 1.37, 95% CI: 0.32 to 2.43). All the investigated probiotic products had fecal incontinence and patient drop-out rates similar to those of placebo/control treatments. Conclusion: The results of our NMA support the application of an advanced combination of probiotics and laxatives for pediatric functional constipation if there is no concurrent contraindication. Registration: PROSPERO (CRD42022298724). What is Known: • Despite of the high prevalence of pediatric constipation, which ranges from 0.7% to 29.6%, the efficacy of pharmacotherapy is limited, with a success rate of 60%. Several randomized controlled trials (RCTs) have shown the benefits of probiotic supplements in treating this condition. However, the reported strains of probiotics varied among the RCTs. The widely heterogeneous strains of probiotics let the traditional meta-analysis, which pooled all different strains into one group, be nonsense and insignificant. What is New: • By conducting a comprehensive network meta-analysis, we aimed to compare the efficacy and acceptability of different strains of probiotic supplements for pediatric functional constipation. Network meta-analysis of nine randomized controlled trials revealed that the most probiotic products, used either alone or combined with laxatives, were associated with significantly better improvement in bowel movement or stool frequency than placebo/control. Protexin plus laxatives was associated with the greatest improvement in bowel movement or stool frequency among all the investigated probiotic products. For the single probiotic interventions, only Lactobacillus casei rhamnosus Lcr35 was associated with significant efficacy compared to placebo/control treatments. All the investigated probiotic products had fecal incontinence and patient drop-out rates similar to those of placebo/control treatments.

The synergistic effect of herbal medicine and probiotics in pediatric functional constipation: A systematic review and meta-analysis.

Pediatric functional constipation (PFC) is a prevalent and persistent gastrointestinal disorder, that requires various treatments, including alternative approaches. This review assessed the synergistic efficacy of herbal medicine (HM) and probiotics for PFC. We conducted a comprehensive search of 11 databases, including English, Chinese, and Korean databases, until June 29, 2023. The inclusion criteria were randomized clinical trials (RCTs) comparing the intervention of HM with probiotics to that of the same probiotics. Statistical analyses included calculation of the mean difference (MD), standardized MD, risk ratio (RR) with a 95% confidence interval (CI), and assessment of risk of bias using Review Manager Version 5.4 software. The Grading of Recommendations Assessment, Development, and Evaluation rating system was used to evaluate evidence quality. Potential publication bias was assessed using funnel plots, Egger test, the fail-safe N test, and Duval and Tweedie trim and fill method. A total of 22 RCTs involving 2228 patients were included in the meta-analysis. The HM and probiotics group exhibited superior outcomes compared to the probiotics alone group in various parameters: total effective rate (RR: 1.24, 95% CI: 1.19-1.29, P < .001), Bristol fecal Score (MD: 0.80, 95% CI: 0.71-0.89, P < .001), gastrointestinal peptide hormone (motilin) (MD: 35.37, 95% CI: 24.64-64.10, P < .001), inflammation indicator (nitrous oxide) (MD: -12.45, 95% CI: -15.12 to -9.77, P < .001), minimal sensitive volume of the rectum (MD: -8.7, 95% CI: -10.91 to -6.49, P < .001), and recurrence rate (RR: 0.30, 95% CI: 0.21-0.43, P < .001). The combination of HM and probiotics may exhibit a synergistic effect on PFC. Nevertheless, it is imperative to undertake rigorously planned RCTs to comprehensively evaluate the synergistic efficacy of HM and probiotics.

The use of polyethylene glycol as a maintenance treatment of functional constipation in children living in Egypt

BackgroundConstipation is an underestimated but common health problem worldwide, decreasing the quality of life. Functional constipation (FC) is a common pediatric problem, with reported prevalence ranging from 0.7 to 29.6%. In Egypt, there are no established guidelines for the treatment of constipation in children.ObjectivesThe aim of this study was to investigate the efficacy of polyethylene glycol (PEG) as a maintenance treatment for functional constipation (FC) in comparison with the classic treatment using (lactulose and senna) in children living in Egypt.Patients and methodThis is a randomized single-blinded clinical trial study on pediatric patients who presented with functional constipation at the outpatient clinic of Cairo University Specialized Pediatric Hospital. The study was conducted on 80 children with functional constipation, who were divided into 2 groups: group 1 (40 children), who received polyethylene glycol as maintenance treatment; group 2 (40 children), who received classic treatment in the form of osmotic laxative (lactulose) with or without stimulant (senna-sennosides or senna-glycoside) according to the stool consistency.ResultsOur data showed significant improvement in the fecal masses and the number of defecation, fecal pseudo incontinence, painful or hard bowel movement, history of retentive posturing or excessive violation, and large fecal masses in the rectum between group 1 and group 2 after treatment. In group 1, there was a significant improvement in anthropometric measures, CBC parameters, abdominal circumference, and anal fissures and piles after treatment; also, there was a significant decrease in the number of patients that need to continue treatment in group 1 in comparison with group 2 and number of patients that had impaction during treatment. However, there was a statistically significant increase in the number of patients who complained of palatability in group 1.ConclusionPEG has long-term efficacy in the management of pediatric functional constipation. Significant improvement of results in comparison with the classic treatment (lactulose or senna-lax).

Comparative efficacy of polyethylene glycol 3350 monotherapy against polyethylene glycol 3350 plus sodium picosulfate combined therapy in treating fecal impaction in pediatric functional constipation patients

Background: Functional constipation (FC) is a common pediatric problem worldwide. The management of FC comprises of a short initial disimpaction phase followed by long-term maintenance phase. Currently, polyethylene glycol (PEG) is considered as standard disimpaction therapy in pediatric FC patients. The aim of our study was to compare the efficacy of polyethylene glycol 3350 monotherapy with polyethylene glycol 3350 and sodium picosulfate combined therapy in treating fecal impaction in pediatric FC patients. Methods: All children (aged &gt;1 year) diagnosed with FC as per ROME IV criteria and presenting to the out-patient department of pediatric gastroenterology, hepatology and nutrition unit of a tertiary health centre in north Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely group A (receiving PEG 3350 monotherapy) and group B (receiving combined PEG 3350 plus sodium picosulfate therapy), over a period of 13 months. The outcome was evaluated as successful disimpaction with onset of loose/watery stools (Type-7 of Bristol stool chart scale). The success rates and mean time to disimpaction for two groups were computed and compared. Results: Eighty-one patients were randomized into two groups. The mean time to disimpaction was found to be significantly lower (p&lt;0.001) for group B (2.37±1.16 days) when compared to group A (4.00±1.43 days). There was successful resolution of impaction in both groups. No adverse events were reported in either group. Conclusions: Combined PEG 3350 and sodium picosulfate therapy significantly reduces the disimpaction time when compared with PEG 3350 monotherapy in pediatric population, however both the therapies appear similar in achieving successful disimpaction.

Jujube Versus Polyethylene Glycol for Maintenance Treatment of Pediatric Functional Constipation: A Randomized Clinical Trial

Background: Functional constipation (FC) is a common major problem in children. This study compared Jujube paste and polyethylene glycol (PEG) as laxative drugs in children with FC. Ziziphus Jujuba Mill (Jujube) was selected according to traditional Iranian medicine because it is native to Iran and a large extent of Asia, is safe and easy to access, with acceptable taste to children. Methods: This randomized controlled clinical trial was performed on 128 children aged 2 to 12 with FC according to Rome IV criteria. Patients were randomly divided into two groups of Jujube paste and PEG and underwent four weeks of treatment. The efficacy, safety, and tolerability of the Jujube oral product were compared with PEG. Results: Following four weeks of therapy, all clinical symptoms of constipation according to Rome IV criteria were improved significantly in both groups (P &lt; 0.05). In all the seven criteria of Rome IV, Jujube paste was as effective as PEG and even stronger in reducing stool stiffness (P &lt; 0.0001). No hazardous side effect was reported in the two groups. Moreover, the medication acceptance rate was higher in the group receiving Jujube paste than in the group receiving PEG. Conclusions: Jujube paste is as effective as PEG in pediatric FC. This product has high nutritional value and antioxidant properties, so it can be a safe substitute for PEG in pediatric FC.

Modified truncated Hochberg procedure for multiple endpoints: An application in a confirmatory trial for pediatric functional constipation

BackgroundIn confirmatory clinical trials, it is critical to have appropriate control of multiplicity for multiple comparisons or endpoints. When multiplicity-related issues arise from different sources (e.g., multiple endpoints, multiple treatment arms, multiple interim data-cuts and other factors), it can become complicated to control the family-wise type I error rate (FWER). Therefore, it is crucial for statisticians to fully understand the multiplicity adjustment methods and the objectives of the analysis regarding study power, sample size and feasibility in order to identify the proper multiplicity adjustment strategy. MethodsIn the context of multiplicity adjustment of multiple dose levels and multiple endpoints in a confirmatory trial, we proposed a modified truncated Hochberg procedure in combination with a fixed-sequence hierarchical testing procedure to strongly control the FWER. In this paper, we provided a brief review of the mathematical framework of the regular Hochberg procedure, the truncated Hochberg procedure and the proposed modified truncated Hochberg procedure. An ongoing phase 3 confirmatory trial for pediatric functional constipation was used as a real case application to illustrate how the proposed modified truncated Hochberg procedure will be implemented. A simulation study was conducted to demonstrate that the study was adequately powered and the FWER was strongly controlled. ConclusionThis work is expected to facilitate the understanding and selection of adjustment methods for statisticians.

Development and evaluation of an interdisciplinary group intervention for pediatric functional constipation.

Development and evaluation of an interdisciplinary group intervention for pediatric functional constipation.

Clinical utility of colonic low-amplitude propagating contractions in children with functional constipation.

Colonic high-amplitude propagating contractions (HAPC) are generally accepted as a marker of neuromuscular integrity. Little is known about low-amplitude propagating contractions (LAPCs); we evaluated their clinical utility in children. Retrospective review of children with functional constipation undergoing low-resolution colon manometry (CM) recording HAPCs and LAPCs (physiologic or bisacodyl-induced) in three groups: constipation, antegrade colonic enemas (ACE), and ileostomy. Outcome (therapy response) was compared to LAPCs in all patients and within groups. We evaluated LAPCs as potentially representing failed HAPCs. A total of 445 patients were included (median age 9.0 years, 54% female), 73 had LAPCs. We found no association between LAPCs and outcome (all patients, p=0.121), corroborated by logistic regression and excluding HAPCs. We found an association between physiologic LAPCs and outcome that disappears when excluding HAPCs or controlling with logistic regression. We found no association between outcome and bisacodyl-induced LAPCs or LAPC propagation. We found an association between LAPCs and outcome only in the constipation group that cancels with logistic regression and excluding HAPCs (p=0.026, 0.062, and 0.243, respectively). We found a higher proportion of patients with LAPCs amongst those with absent or abnormally propagated (absent or partially propagated) HAPCs compared to those with fully propagated HAPCs (p=0.001 and 0.004, respectively) suggesting LAPCs may represent failed HAPCs. LAPCs do not seem to have added clinical significance in pediatric functional constipation; CM interpretation could rely primarily on the presence of HAPCs. LAPCs may represent failed HAPCs. Larger studies are needed to further validate these findings.

Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial

Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial

Cross-cultural adaptation, validity, and reliability of the pediatric constipation score-parent report in pediatric functional constipation in an Iranian population.

We evaluated the Persian version of the pediatric constipation score-parent report (PCS) validity and reliability. Functional constipation in children results in physical and psychological problems. Therefore, it is necessary to utilize a questionnaire to assess the health-related quality of life in children with chronic constipation. First, our team translated the English version of the questionnaire into the Persian language. Second, the psychometric properties of the Persian version were collected in 149 children with functional constipation referred to a pediatrics hospital by an expert team. We assessed content validity (CV) through the CV index (CVI) and CV ratio (CVR). The construct validity was evaluated by exploratory factor analysis, and reproducibility was tested based on test-retest reliability using the intra-class correlation coefficient (ICC). Internal consistency was calculated using Cronbach's α. we also evaluated the ceiling or floor. Results showed acceptable CVI in relevancy, clarity, and simplicity, acceptable CVR for all items, moderate internal consistency (Cronbach's alpha=0.548), and almost perfect reproducibility (ICC=0.93). No ceiling or floor effect was seen. The Persian version of PCS showed good validity and reliability in children with functional constipation in Iran. Therefore, we can use it in clinical and research domains in Persian-speaking countries.

Comparative efficacy of polyethylene glycol 3350 and psyllium in treatment of pediatric functional constipation: A randomized and controlled trial

Background: Functional constipation (FC) is a common childhood problem worldwide. At present, polyethylene glycol (PEG) is considered as standard therapy in pediatric FC patients. Aims and Objectives: The aim of the study was to compare the efficacy of PEG 3350 versus psyllium in treatment of pediatric FC. Materials and Methods: All children (aged &gt;1 year) diagnosed with FC according to Rome IV criteria and presenting to the outpatient department of Pediatric Gastroenterology, Hepatology, and Nutrition Unit of a tertiary health center in North Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely, Group A (receiving PEG 3350) and Group B (receiving psyllium), over a period of 16 months. The comparative efficacy was evaluated by comparing the percent of patients with successful outcomes in two groups at 4, 8, and 12 weeks of therapy and the rate of recurrence of impaction in two groups was also assessed and compared over same period. Results: Eighty-one patients were randomized into two groups. A significantly higher number of patients in Group A was successfully treated after 4 weeks (Group A 68.3% vs. Group B 42.5%; P = 0.026), 8 weeks (Group A 80.0% vs. Group B 57.9%; P = 0.049), and 12 weeks (Group A 92.3% vs. Group B 67.6%; P = 0.009) of treatment compared with Group B. Impaction recurred in two patients in Group B while no recurrence was observed in any of the Group A patients but the difference observed was not statistically significant (P = 0.494). No significant adverse events were reported in either groups. Conclusion: PEG 3350 was found to be significantly more effective than psyllium in improving the symptoms of constipation in pediatric patients.

Efficient methods of therapy of pediatric functional constipation

Constipation holds an important place among the functional gastrointestinal disorders. The following are among the main reasons for the development of functional constipation: alimentary factors, impaired nervous and endocrine regulation (functional immaturity of the colon, perinatal injury of the central nervous system, endocrine disease), psychosomatic factors, hypodynamia, previous intestinal infections, iatrogenic effects, food allergies and anorectal pathology, genetic predisposition. Treatment of constipation should be comprehensive and include lifestyle maneuvers, dietary recommendations, dietary fibres and water schedule, pharmacotherapy, biofeedback, and surgical methods. Stimulant laxatives (sodium picosulfate, bisacodyl) are effective drugs among the medications used to treat constipation. A sodium picosulfate drug is an effective stimulant laxative, which has a triple effect: stimulation of bowel movements, reduction of the evacuation time and softening stools. The efficacy and safety of the drug was studied in a multicenter, parallel, double-blind, randomized, placebo-controlled study in patients with chronic constipation. The article presents our own experience – a clinical observation – of the use of sodium picosulfate. 26 children with chronic constipation aged from 1 to 7 years, who had stool retention from 3 to 7 days, were observed. The inclusion of a stimulant sodium picosulfate laxative in the comprehensive functional chronic constipation therapy in children aged 1 to 7 years at age-specific dosage variances for 7 days showed high clinical efficacy, which resulted in the normalization of stool in 76.9% of children, facilitating bowel movements and improvement of children’s well-being. This drug can be recommended in the comprehensive therapy of functional constipation in children.

Diverting Ileostomy in Children With Functional Constipation: A Study Evaluating the Utility of Colon Manometry.

Pediatric functional constipation (FC) may require invasive evaluations [like colon manometry (CM)] and surgical interventions [including diverting ostomy (DO)]. We evaluated the utility of CM in guiding surgery after DO. Children with medically refractory FC undergoing an ostomy were included. Institutional Review Board approval was obtained for this retrospective study. Demographics and CM variables [high amplitude propagating contractions (HAPCs)] were recorded. Outcome measures: response to ostomy closure defined as successful if no need for further surgery after ostomy closure, and improvement on baseline CM after ostomy. A CM-guided ostomy closure algorithm was developed based on previous studies. We evaluated the association between response to ostomy closure and demographics, ostomy indication and CM improvement, and evaluated the role of CM predicting response using algorithm. A total of 60 children underwent ostomy for FC (median age: 7.1 years, range 0.15-23.6 years, 50% female). Ostomy was closed in 30 patients and deemed successful in 23 of 30. CM was performed in 42 of 60 patients before ostomy and in 29 of 30 before ostomy closure. We found no association between ostomy outcome and age, gender, weight, imaging studies, follow-up time, time with ostomy, HAPCs, and CM improvement. We found an association between failed response and ostomy indication of antegrade colonic enemas (ACE) failure ( P = 0.026) and successful response when ostomy closure was guided by algorithm ( P = 0.03). DO is a useful intervention in selected children with medically refractory FC, improving colon motility in most. CM can successfully guide the timing and type of ostomy closure. Larger studies are needed to further validate our findings.

Saudi Experts Consensus on Diagnosis and Management of Pediatric Functional Constipation.

Although functional gastrointestinal disorders (FGIDs) are very common in pediatric patients, there is a scarcity of published epidemiologic data, characteristics, and management patterns from Saudi Arabia, which is the 2nd largest Arabic country in terms of area and the 6th largest Arabic country in terms of population, with 10% of its population aged <5 years. Functional constipation (FC) is an FGID that has shown a rising prevalence among Saudi infants and children in the last few years, which urges us to update our clinical practices. Nine pediatric consultants attended two advisory board meetings to discuss and address current challenges, provide solutions, and reach a Saudi national consensus for the management of pediatric constipation. The pediatric consultants agreed that pediatricians should pay attention to any alarming signs (red flags) found during history taking or physical examinations. They also agreed that the Rome IV criteria are the gold standard for the diagnosis of pediatric FC. Different therapeutic options are available for pediatric patients with FC. Dietary treatment is recommended for infants with constipation for up to six months of age. When non-pharmacological interventions fail to improve FC symptoms, pharmacological treatment with laxatives is indicated. First, the treatment is aimed at disimpaction to remove fecal masses. This is achieved by administering a high dose of oral polyethylene glycol (PEG) or lactulose for a few days. Subsequently, maintenance therapy with PEG should be initiated to prevent the re-accumulation of feces. In addition to PEG, several other options may be used, such as Mg-rich formulas or stimulant laxatives. However, rectal enemas and suppositories are usually reserved for cases that require acute pain relief. In contrast, infant formulas that contain prebiotics or probiotics have not been shown to be effective in infant constipation, while the use of partially hydrolyzed formula is inconclusive. These clinical practice recommendations are intended to be adopted by pediatricians and primary care physicians across Saudi Arabia.

Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial.

Background: Polyethylene glycol (PEG) is recommended as first-line treatment of pediatric functional constipation. However, the oral route of administration is often poorly feasible in children mostly due to poor palatability. Promelaxin microenemas exert a topical evacuative action and may offer a valuable option in pediatric FC.Aim: To assess whether Promelaxin microenemas would be non-inferior to PEG 4000 in young children with FC.Methods: This is a randomized, open-label, multi-centric, non-inferiority trial enrolling infants and young children aged 6–48 months, with FC according to Rome III criteria. After 1 week of run in, children were randomized to 2 weeks of Promelaxin or PEG, followed by a 6-week on-demand treatment period. Primary endpoint was response rate to randomized treatment, with “response” defined as at least 3 evacuations per week and an average increase of at least one evacuation per week as compared to baseline. Safety, stool consistency and the analysis of fecal microbiota were secondary endpoints.Results: Out of the 158 patients who entered the trial, 153 patients were treated (77 and 76, PEG and Promelaxin arm, respectively). In the primary analysis, the 95% confidence interval (CI) for the treatment's effect lay entirely above the non-inferiority margin in both Full Set (FAS) and Per Protocol (PP) analyses, providing evidence of the non-inferiority of Promelaxin vs. PEG 4000 [response rate difference: 16.5% (CI 1.55–31.49%) and 11.03% (CI −5.58 to 27.64%), FAS and PP analyses, respectively]. Mean compliance to the randomized treatment was >80% in both arms. Secondary endpoints did not significantly differ between the two arms, except for the average number of total days of on-demand treatment that was significantly lower in the Promelaxin arm [14.6 (12.7) vs. 9.8 (9.1), mean (SD); primary endpoint responders in PEG and Promelaxin arm, respectively; p = 0.027]. Microbiota evenness significantly increased in the PEG 4000 arm at V4 as compared to the Promelaxin arm (p < 0.05). In addition, at V5, patients treated with PEG showed a significantly decreased microbiota density as compared to patients treated with Promelaxin (p = 0.036).Conclusions: Promelaxin microenemas are non-inferior to oral PEG in children with FC.Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02751411.

What is the Evidence for Over the Counter Laxatives to Treat Childhood Constipation?

Functional constipation is a common pediatric GI disorder that is responsible for a significant portion of pediatric office visits each year. It presents a significant stressor for patients, their families, and providers alike. There are a variety of over the counter agents available for treatment of pediatric constipation. Osmotic laxatives, such as polyethylene glycol 3350 (PEG 3350) and lactulose, remain the most effective and safe therapy for both long and short term treatment of pediatric functional constipation. Stimulant laxatives, like Senna and Bisacodyl, probiotics, fiber preparations, enemas, and suppositories make excellent choices for adjunct therapies in specific clinical scenarios. There are multiple over the counter pharmacologic agents with various mechanisms of action that have demonstrated efficacy in pediatric functional constipation. These therapies are generally safe and well tolerated by patients.

Effectiveness of Viola Flower Syrup Compared with Polyethylene Glycol in Children with Functional Constipation: A Randomized, Active-Controlled Clinical Trial.

Background Functional constipation (FC) is a health concern that is prevalent in the pediatric population. It lowers the quality of life and increases the probability of comorbidities. As a complementary modality, herbal medicine has been considered useful in a variety of conditions. Persian medicine (PM) resources mention the Viola flower as an effective herb in treating constipation. The purpose of the current trial was to evaluate the efficacy of Viola flower syrup (VFS) compared with polyethylene glycol (PEG) in children with functional constipation. Methods This randomized, active-controlled, single-center trial was conducted on 140 children aged between 4 and 10 years with confirmed FC according to Rome III criteria. Participants were randomly assigned to receive either VFS or PEG for four weeks. Independent t-test and general linear model (GLM) repeated measures analysis of variance were used to determine the intergroup difference, and paired sample t-test was used to evaluate the intragroup difference. Results After four weeks of intervention, 133 individuals (66 in VFS and 67 in the PEG group) were analyzed. Results of both groups demonstrated significant improvement in all measured criteria at the end of the study compared to baseline (P < 0.001). No significant difference was observed between the two groups at baseline or at the end of the study (P > 0.05), except for fecal retention at baseline (P=0.028). Participants in the PEG group experienced more side effects compared to the VFS group. Conclusion The findings of this investigation indicated that VFS is an effective and relatively safe medication to be used in the treatment of pediatric FC.

Melanosis Coli Is Not Associated with Colonic Dysmotility Nor Severity of Pediatric Functional Constipation.

Sennosides are commonly used for the treatment of constipation and associated with melanosis coli. In the present study, we evaluated the utility of melanosis coli as a marker of severity and its association with colonic motility in children with functional constipation. Prospective study includes pediatric patients undergoing colonic manometry and colonic biopsies. Demographic data, medication history, surgical history, colonic manometry results (gastrocolonic response to a meal, high-amplitude propagating contractions, and nonpropagating contractions), colonic manometry catheter position, and pathologic results were collected and analyzed. We compared those variables with outcome (need for surgery) between both patient groups (presence or absence of melanosis coli). A total of 150 patients were included, median age was 9.9years (range 2.1-18) and 77 (51.3%) were female, 17 had melanosis. Patients who took sennosides had higher rates of melanosis coli compared to those who did not (adjusted OR 13.88; 95% CI 4.05-47.57; P < 0.001), and we did not find an association between melanosis coli and use of other medications (osmotic laxatives, bisacodyl, lubiprostone), age, gender, weight, and height. We found no significant difference in the results colonic manometry between patients with and without melanosis coli. The rates of surgery for constipation between patients with and without melanosis coli were not statistically different. (OR 3.00; 95% CI 0.45-20.07; P = 0.257). Melanosis coli is associated with sennosides use, but it does not influence colonic motility nor is associated with increased subsequent need for surgery in pediatric functional constipation.

Red Sugar versus Polyethylene Glycol 3350 in Pediatric Functional Constipation: A randomized and Active-Controlled Trial

Red Sugar versus Polyethylene Glycol 3350 in Pediatric Functional Constipation: A randomized and Active-Controlled Trial

Pediatric Functional Constipation Questionnaire-Parent Report (PedFCQuest-PR): development and validation

ObjectiveDeveloping and validating a disease-specific instrument in the Brazilian Portuguese language to assess the Health-Related Quality of Life of children with functional constipation, applied to parents/caregivers. MethodsThe process of developing the questionnaire was carried out in the following steps: items generation concerning functional constipation; elaboration of the preliminary questionnaire; assessment by health professionals; identifying problems or inconsistencies by the researchers; improvement of the questions; obtaining a final questionnaire named Pediatric Functional Constipation Questionnaire-Parent Form (PedFCQuest-PR) with 26 questions divided into four domains. Responses options use a Likert scale based on the events of the last four weeks. The process of validation was an observational, cross-sectional study in a sample of 87 parents/caregivers of children from 5 to 15 years of age diagnosed with Functional constipation according to the Rome IV Criteria. The questionnaire was applied simultaneously to the Pediatric Quality of Life Inventory 4.0 (PedsQL TM 4.0) as a control. ResultsThe questionnaire validation included 87 parents/caregivers. The children's median age was 8.2 years, with a long time of constipation symptoms associated with fecal incontinence in approximately two-thirds. Internal consistency reliability for the Total Scale Score of PedFCQuest-PR by Coefficient Alpha of Cronbach score was 0.86. Convergent and divergent validity of PedFCQuest-PR was demonstrated by correlating the domains of both questionnaires. ConclusionThis study provides evidence that PedFCQuest-PR is a reliable instrument. The results showed a high degree of internal consistency and validity of the instrument for future applications.