NCT06488274 Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
| NCT ID | NCT06488274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | United Pharmaceuticals |
| Condition | Functional Gastrointestinal Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 139 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 139 participants in total. It began in 2024-10-21 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Christophe Batard, Dr.
STUDY DIRECTOR
Ambulatory pediatrician in Vincennes (France)
Frequently Asked Questions
Who can join the NCT06488274 clinical trial?
This trial is open to participants of all sexes, up to 4 Months, studying Functional Gastrointestinal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488274 currently recruiting?
Yes, NCT06488274 is actively recruiting participants. Contact the research team at as.garreau@novalac.com for enrollment information.
Where is the NCT06488274 trial being conducted?
This trial is being conducted at Nice, France, Paris, France, Toulon, France, Vincennes, France.
Who is sponsoring the NCT06488274 clinical trial?
NCT06488274 is sponsored by United Pharmaceuticals. The principal investigator is Christophe Batard, Dr. at Ambulatory pediatrician in Vincennes (France). The trial plans to enroll 139 participants.