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Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of a Food Supplement on IBS in Children

NCT06123234 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-07-16

No results posted yet for this study

Summary

The goal of this clinical trial is to test a food supplement in children of 3-17 years with IBS. The main questions it aims to answer are:

* Is the tested supplement able to improve and/or reduce IBS-related symptoms?
* After administration of the food supplement, how does the state of intestinal inflammation improve?
* Is the gut microbiota modified?

Participants will take the food supplement every day for 2 months. After 30 days and after 60 days, they will be visited from the gastroenterologist.

* They have to fill in the questionnaire and the symptom's diary weekly and deliver it to the gastroenterologist during the visits
* At the first visit, they will collect the faecal sample for the analysis of inflammatory markers and gut microbiota
* After 30 days, they will collect the faecal sample for the analysis of inflammatory markers
* After 60 days, they will collect the faecal sample for the analysis of gut microbiota Researchers will compare with placebo to see if the product is effective.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Verum

Food supplement in single-dose vials

OTHER

Placebo

Food supplement in single-dose vials

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123234 on ClinicalTrials.gov