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New treatment option for Functional Gastrointestinal Disorders
Official title Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
ClinicalTrials.gov ID: NCT06488274
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 4
You may be able to join if
- 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...
- Infants born at 35 weeks or more of gestational age
- Infants up to 4 months of age
You likely can't join if
- Exclusively or partially breastfed infants (i.e. \> 2 breast feeds per day) with maternal willingness to continue breastfeeding
- Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
- Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
- The willingness to take additional pre-, probiotics or thickening agents during the study
- Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
- Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may...
The study team makes the final eligibility decision.
Where it's taking place
- Nice, France
- Paris, France
- Toulon, France
- Vincennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 4 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, France; Paris, France; Toulon, France; Vincennes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.