Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children. (NCT04922476) | Clinical Trial Compass
CompletedNot Applicable
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
Chile65 participantsStarted 2021-08-06
Plain-language summary
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion criteria
✓. Age 8-18 years
✓. Any sex
✓. ROME IV diagnostic criteria Pediatric functional digestive disorders: in children and adolescents. H2. Functional abdominal pain disorders H2a. Functional dyspepsia H2b. Irritable bowel syndrome H2d. Functional abdominal pain not otherwise specified H3. Functional defecation disorders H3a. Functional constipation H3b. Non-retentive fecal incontinence Meet the criteria during the last three months with the onset symptoms for at least six months before diagnosis
✓. IBS rated moderate to severe according to GSRS-IBS score (Spanish / LA)
✓. At least two episodes of abdominal pain per week
✓. No consumption of probiotics at least two weeks before baseline measurements (but preferably four weeks);
✓. Dad, Mom, or Guardian able to understand the protocol;
✓. Be willing to maintain stable dietary habits throughout the study period;
Exclusion criteria
✕. Children with systemic, organic or metabolic diseases, immunosuppression, different from IBS
✕. Previous major abdominal surgery;
✕. Consumption of proton pump inhibitors, H2 antagonists;
✕. Consumption of probiotics in the two weeks before baseline measurements;
What they're measuring
1
Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)
Timeframe: Change from baseline, assessed at 6 and 12 weeks of supplement intake
2
Change in abdominal pain assessed by the Numeric Rating Scale for pain
Timeframe: Change from baseline, assessed at 6 and 12 weeks of supplement intake
✕. Are less than 8 or older than 18 years of age at the time of consent;
✕. Subject who has been on antibiotics during the past 3 months;
✕. Subjects who have not had at least two episodes of abdominal pain per week;
✕. Subject with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection;