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

Recruiting now · Not applicable

Conditions studied: Functional Gastrointestinal Disorders

In brief

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.

Key facts

Study ID: NCT06488274
Run by: United Pharmaceuticals
People needed: 139
Starts: 2024-10-21
Expected to finish: 2026-04-01
Last updated by the study team: 2025-01-06

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
1 Regurgitations: 1.2 Colic: 1.3 Constipation:
Infants born at 35 weeks or more of gestational age
Infants up to 4 months of age

You may not qualify if…

Exclusively or partially breastfed infants (i.e. \&amp;gt; 2 breast feeds per day) with maternal willingness to continue breastfeeding
Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
The willingness to take additional pre-, probiotics or thickening agents during the study
Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient
(non exhaustive list)

Where it is running

Site 03 — Toulon, France (enrolling)
Site 01 — Vincennes, France (enrolling)
Site 02 — Nice, France
Site 04 — Paris, France

Full record on ClinicalTrials.gov

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