Actively Recruiting
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Led by United Pharmaceuticals · Updated on 2025-01-06
139
Participants Needed
4
Research Sites
75 weeks
Total Duration
On this page
Sponsors
U
United Pharmaceuticals
Lead Sponsor
A
Axiodis CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with at least one functional gastrointestinal disorder (regurgitations, colic, or constipation) based on adapted Rome IV criteria
- Born at 35 weeks or more of gestational age
- Up to 4 months of age
You will not qualify if you...
- Exclusively or partially breastfed infants with more than 2 breast feeds per day and maternal willingness to continue breastfeeding
- Infants who are diversified or whose parents plan to start diversification within 2 weeks of the study
- Use of antibiotics at inclusion visit or within 7 days before
- Plans to take additional prebiotics, probiotics, or thickening agents during the study
- Known allergy or intolerance to any ingredient of the product or suspected cow's milk allergy requiring an eviction diet
- Any other condition or participation in another clinical trial that the investigator believes may interfere or pose risk during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Site 02
Nice, France
Not Yet Recruiting
2
Site 04
Paris, France
Not Yet Recruiting
3
Site 03
Toulon, France
Actively Recruiting
4
Site 01
Vincennes, France
Actively Recruiting
Research Team
A
Anne-Sophie Garreau
CONTACT
C
Caroline Thevret, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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