Status:
RECRUITING
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Lead Sponsor:
United Pharmaceuticals
Collaborating Sponsors:
Axiodis CRO
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
All Genders
Up to 4 years
Phase:
NA
Brief 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) (GI...
Detailed Description
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusively or partially breastfed infants (i.e. \> 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)
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT06488274
Start Date
October 21 2024
End Date
April 1 2026
Last Update
January 6 2025
Active Locations (4)
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1
Site 02
Nice, France
2
Site 04
Paris, France
3
Site 03
Toulon, France
4
Site 01
Vincennes, France