Testing a food supplement for children with IBS
Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of the Food Effect of the Food Supplement Enterokind® Junior on Irritable Bowel Syndrome (IBS) in Children
This study is testing a food supplement to see if it can help children aged 3 to 17 with Irritable Bowel Syndrome feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Policlinico "G. Martino" Academic / other |
| Locations | 1 site (Messina) |
| Trial ID | NCT06123234 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a food supplement in children aged 3 to 17 years with Irritable Bowel Syndrome (IBS). Participants will take the supplement daily for two months while monitoring their symptoms through questionnaires and diaries. The study will assess changes in intestinal inflammation and gut microbiota by collecting fecal samples at various intervals. The results will be compared to a placebo group to determine the supplement's efficacy.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 years diagnosed with IBS according to the Rome IV criteria.
Not a fit: Patients with serious illnesses, psychiatric comorbidities, or those with confirmed sensitivity to the supplement's components may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention to alleviate IBS symptoms in children.
How similar studies have performed: Other studies have shown promising results with similar probiotic interventions for IBS, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects presenting symptoms of IBS according to Rome IV criteria. * Presence of functional disorders according to assessment questionnaire with a score of 2 or more. * Age between 3 and 17 years and 11 months. * Willingness of the subject/parent to participate in the study. * Willingness of the subject/parent to complete the questionnaire. * Willingness of subject/parent to use only the product to be tested during the duration of the study. * Willingness of the subject/parent not to use similar products during the duration of the study. * Parent's signature of informed consent. Exclusion Criteria: * Subjects who do not meet the inclusion criteria. * Subjects considered unfit by the referring physician. * Subjects with suspected or confirmed sensitivity to one or more components of the product. * Subjects with psychiatric comorbidities. * Subjects with serious illnesses. * Subjects with differential diagnoses (functional dyspepsia, coeliac disease, IBD, food intolerances, individual hypersensitivities). * Subjects undergoing ongoing pharmacological treatment, inherent to the disease (e.g. spasmolytics etc.). * Subjects who have recently (two weeks or less) undergone antibiotic therapy * Subjects with other concomitant diseases (immune, infectious, respiratory or gastro-intestinal). * Subjects with growth restriction. * Subjects with congenital malformations.
Where this trial is running
Messina
- Gioacchino Calapai — Messina, Italy (Recruiting)
Study contacts
- Study coordinator: Claudio Romano, Associate Professor
- Email: claudio.romano@unime.it
- Phone: +39 090 2213818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.