Overview
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.
Description
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
Eligibility
Inclusion Criteria:
- 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:
- Infants born at 35 weeks or more of gestational age
- Infants up to 4 months of age
Exclusion Criteria:
- 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)