Status:
UNKNOWN
Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of a Food Supplement on IBS in Children
Lead Sponsor:
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief 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...
Detailed Description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterised essentially by abdominal pain and alterations in bowel movements. IBS is linked to a sensory and intestinal motor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06123234
Start Date
April 1 2023
End Date
April 1 2025
Last Update
July 16 2024
Active Locations (1)
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1
Gioacchino Calapai
Messina, Italy, 98125