Assessing a new infant formula for gastrointestinal disorders in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site 03
  Toulon, France Recruiting
• Site 01
  Vincennes, France Recruiting
• Site 02
  Nice, France Not yet recruiting
• Site 04
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Anne-Sophie Garreau
• Email: as.garreau@novalac.com
• Phone: 0033-155372222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.