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

RecruitingNAAges any - 4 MonthsAllUnited Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • New infant formula
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Where

4 sites
Site 02
Nice, France
Site 04
Paris, France
Site 03
Toulon, France
Site 01
Vincennes, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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