Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

Launched by UNITED PHARMACEUTICALS · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a new infant formula affects babies with functional gastrointestinal disorders (FGIDs), which are common digestive issues like regurgitation, colic, and constipation. The researchers want to understand how these conditions change in infants who are fed this specific formula. The study is open to infants who are at least 35 weeks old and up to 4 months of age, as long as they are experiencing at least one of the FGIDs mentioned.

To participate, infants cannot be exclusively or mostly breastfed, and they shouldn’t be starting solid foods during the study. They also should not have taken antibiotics recently or have known allergies to any ingredients in the formula. If a baby joins the trial, their progress will be monitored using a special scale that measures gastrointestinal symptoms. This is an important opportunity for families looking for solutions to their baby's digestive issues, and it may help researchers learn more about how to support infants with FGIDs.

Gender

ALL

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)