Phase
Condition
Ulcers
Bowel Dysfunction
Gastrointestinal Diseases And Disorders
Treatment
New infant formula
Clinical Study ID
Ages < 4 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Infants presenting with at least one of the FGIDs below, defined based on adaptedRome 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
Exclusion Criteria:
Exclusively or partially breastfed infants (i.e. &amp;gt; 2 breast feeds perday) with maternal willingness to continue breastfeeding
Diversified infants or whose parents intend to start diversification within thefirst 2 weeks of the study
Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusionvisit (V0)
The willingness to take additional pre-, probiotics or thickening agents during thestudy
Known allergy/intolerance to any of the product ingredients or suspected allergy tocow's milk requiring an eviction diet
Infants presenting with any other situation including the participation in anotherclinical trial, which, according to the investigator, may interfere with the studyparticipation, or lead to a particular risk for the patient
(non exhaustive list)
Study Design
Study Description
Connect with a study center
Site 02
Nice,
FranceSite Not Available
Site 04
Paris,
FranceSite Not Available
Site 03
Toulon,
FranceActive - Recruiting
Site 01
Vincennes,
FranceActive - Recruiting
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