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

Recruiting N/A Interventional Study
Functional Gastrointestinal Disorders
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
Up to 4 Months
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
139 (estimated)
Sponsor
United Pharmaceuticals · Industry
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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.

Trial Locations
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Eligibility Criteria
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.…
Contacts

Anne-Sophie Garreau

0033-155372222

as.garreau@novalac.com

CONTACT

Caroline Thevret, Dr.

0033-155372222

c.thevret@novalac.com

CONTACT