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

NCT06123234 | Unknown

• 1 other identifier: ENTJR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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-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

Outcome Measures

Primary Outcomes (2)

• Evaluation of the relief of IBS related symptoms

  Evaluation of the relief of IBS related symptoms by means of a questionnaire to be completed during visits, which follows SGARC (Subject's Global Assessment Relief for Children) validated 5-points scale (from 0 to 4, where 0 = complete relief and 4 = worsening).

  T0 (first visit - day 0), T30 days, T60 days

• Evaluation of the reduction of IBS related symptoms

  Evaluation of the reduction of IBS related symptoms by means of a 2-questions questionnaire to be completed during visits

  T0 (first visit - day 0), T30 days, T60 days

Secondary Outcomes (2)

• Variation of inflammatory markers and of the gut microbiota

  T0 (first visit - day 0), T30 days

• Metagenomic analysis of the gut microbiota

  T0 (first visit - day 0), T 60 days

Study Arms (2)

Verum

EXPERIMENTAL

Partecipants received a food supplement with probiotics, chamomile, vitamin A, vitamin D in single-dose vials every day for 60 days.

Dietary Supplement: Verum

Placebo

PLACEBO COMPARATOR

Placebo does not contain any active ingredients. Partecipants received placebo in single-dose vials every day for 60 days.

Other: Placebo

Interventions

Verum DIETARY_SUPPLEMENT

Food supplement in single-dose vials

Verum

Placebo OTHER

Food supplement in single-dose vials

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, 98125, Italy

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Claudio Romano, Associate Professor

CONTACT

+39 090 2213818; claudio.romano@unime.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: different batch code assigned to products, same labeling
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind verum vs placebo

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: November 8, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2023-11

Locations

IT (1)