Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 4
SponsorUnited Pharmaceuticals
About this trial
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 criteria
Qualifiers
Infants born at 35 weeks or more of gestational age
Infants up to 4 months of age
Disqualifiers
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
Trial design
Treatments tested in this trial
- New infant formula
Treatment groups
139 Participants
are divided into 1 treatment groupSponsors and collaborators
United Pharmaceuticals
Lead sponsor
Axiodis CRO
Collaborator
Source ClinicalTrials.gov