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
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.
• 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.