Trials / Recruiting
RecruitingNCT06488274
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 139 (estimated)
- Sponsor
- United Pharmaceuticals · Industry
- Sex
- All
- Age
- 4 Months
- Healthy volunteers
- Not accepted
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.
Detailed description
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | New infant formula | The new formula will be given to infants during the 4-month study period. |
Timeline
- Start date
- 2024-10-21
- Primary completion
- 2025-12-01
- Completion
- 2026-04-01
- First posted
- 2024-07-05
- Last updated
- 2025-01-06
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06488274. Inclusion in this directory is not an endorsement.