NCT06108401

Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 14 Days – 90 Days
• Healthy volunteers: Accepted

Summary

In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.

Detailed description

Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies. In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.

Conditions

• Infant Nutrition Disorders
• Gastrointestinal Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Goat milk-based infant formula	Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.
DIETARY_SUPPLEMENT	Cow milk-based infant formula	Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-10-31
• Last updated: 2023-10-31

Locations

1 site across 1 country: Poland