Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

Last updated: January 2, 2025
Sponsor: United Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Bowel Dysfunction

Gastrointestinal Diseases And Disorders

Treatment

New infant formula

Clinical Study ID

NCT06488274
UP2022_FGID
  • Ages < 4
  • All Genders

Study Summary

This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Infants presenting with at least one of the FGIDs below, defined based on adaptedRome IV criteria as follows:

1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:

  1. Infants born at 35 weeks or more of gestational age

  2. Infants up to 4 months of age

Exclusion

Exclusion Criteria:

  1. Exclusively or partially breastfed infants (i.e. &amp;amp;gt; 2 breast feeds perday) with maternal willingness to continue breastfeeding

  2. Diversified infants or whose parents intend to start diversification within thefirst 2 weeks of the study

  3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusionvisit (V0)

  4. The willingness to take additional pre-, probiotics or thickening agents during thestudy

  5. Known allergy/intolerance to any of the product ingredients or suspected allergy tocow's milk requiring an eviction diet

  6. Infants presenting with any other situation including the participation in anotherclinical trial, which, according to the investigator, may interfere with the studyparticipation, or lead to a particular risk for the patient

(non exhaustive list)

Study Design

Total Participants: 139
Treatment Group(s): 1
Primary Treatment: New infant formula
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
April 30, 2026

Study Description

The study comprises a first period of 30 days followed by an optional intervention period of 90 days.

Connect with a study center

  • Site 02

    Nice,
    France

    Site Not Available

  • Site 04

    Paris,
    France

    Site Not Available

  • Site 03

    Toulon,
    France

    Active - Recruiting

  • Site 01

    Vincennes,
    France

    Active - Recruiting

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