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 range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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;