Assessing a new infant formula for gastrointestinal disorders in infants
Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
This study tests a new infant formula to see if it helps babies with tummy troubles feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | N/A to 4 Months |
| Sex | All |
| Sponsor | United Pharmaceuticals Industry-sponsored |
| Locations | 4 sites (Nice and 3 other locations) |
| Trial ID | NCT06488274 on ClinicalTrials.gov |
What this trial studies
This study evaluates how a new infant formula affects functional gastrointestinal disorders (FGIDs) in infants. It employs the Gastrointestinal and gastroesophageal reflux (GIGER) scale to measure outcomes over a 30-day initial period, followed by an optional 90-day intervention phase. The study is open-label and non-comparative, involving multiple centers to gather diverse data on infant responses to the formula.
Who should consider this trial
Good fit: Ideal candidates are infants aged up to 4 months who exhibit symptoms of FGIDs such as regurgitation, colic, or constipation.
Not a fit: Infants who are exclusively or partially breastfed or those with known allergies to the formula's ingredients may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary option for infants suffering from FGIDs, potentially improving their comfort and health.
How similar studies have performed: While there have been studies on infant formulas, this specific approach focusing on FGIDs with a new formula is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nice and 3 other locations
- Site 02 — Nice, France (Not_yet_recruiting)
- Site 04 — Paris, France (Not_yet_recruiting)
- Site 03 — Toulon, France (Recruiting)
- Site 01 — Vincennes, France (Recruiting)
Study contacts
- Study coordinator: Anne-Sophie Garreau
- Email: as.garreau@novalac.com
- Phone: 0033-155372222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.