Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: f
View:
• Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
⁃ 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
Locations
Other Locations
France
Site 02
NOT_YET_RECRUITING
Nice
Site 04
NOT_YET_RECRUITING
Paris
Site 03
RECRUITING
Toulon
Site 01
RECRUITING
Vincennes
Contact Information
Primary
Anne-Sophie Garreau
as.garreau@novalac.com
0033-155372222
Backup
Caroline Thevret, Dr.
c.thevret@novalac.com
0033-155372222
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-04
Participants
Target number of participants: 139
Treatments
Experimental: Test formula
The test product is a thickened infant formula containing symbiotic (fibers and probiotics)
Related Therapeutic Areas
Sponsors
Collaborators: Axiodis CRO
Leads: United Pharmaceuticals