Ireland
--:--IST
Recruiting Not applicable

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

NCT06488274 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-10-21
Last updated
2025-01-06

Condition(s) studied

Functional Gastrointestinal Disorders

Investigational drug(s) / intervention(s)

New infant formula

New infant formula: The new formula will be given to infants during the 4-month study period.

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

Sex
ALL
Min age
—
Max age
4 Months
Healthy volunteers
No
Inclusion Criteria: 1. Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows: 1.1 Regurgitations: 1.2 Colic: 1.3 Constipation: 2. Infants born at 35 weeks or more of gestational age 3. Infants up to 4 months of age Exclusion Criteria: 1. Exclusively or partially breastfed infants (i.e. \> 2 breast feeds per day) with maternal willingness to continue breastfeeding 2. Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study 3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0) 4. The willingness to take additional pre-, probiotics or thickening agents during the study 5. Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet 6. 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)

Primary outcome measure(s)

  • Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score — Day 30
    The main outcome will be the evolution of the sum score of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale (Pados et al., 2021). The GIGER score varies from 0 to 180 being the worst.

Trial sites (4)

FacilityCityRegionStatus
Site 02 Nice France Not Yet Recruiting
Site 04 Paris France Not Yet Recruiting
Site 03 Toulon France Recruiting
Site 01 Vincennes France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06488274 on ClinicalTrials.gov ↗ ← All trials in France