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

United Pharmaceuticals

Status: Enrolling

Conditions: Functional Gastrointestinal Disorders

Treatments: Dietary Supplement: New infant formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06488274

UP2022_FGID

Details and patient eligibility

About

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.

Full description

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

Enrollment: 139 estimated patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

Test formula

Experimental group

Description:

The test product is a thickened infant formula containing symbiotic (fibers and probiotics)

Treatment:

Dietary Supplement: New infant formula