Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula

Starting soon · Not applicable

Conditions studied: Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life, Anthropometrics

In brief

This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.

Key facts

Study ID

NCT07342972

Run by

Ausnutria Hyproca B.V.

People needed

144

Starts

2026-02-01

Expected to finish

2027-09-01

Last updated by the study team

2026-01-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 14 days and 90 days.
• Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.
• Infants who have received CMF for at least 7 consecutive days.
• Exclusive formula feeding.
• Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and <10.
• Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol

You may not qualify if…

• Exclusively or partially feeding with human milk
• Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement
• Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters.
• Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance.
• Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication)
• Sibling already participating in this study
• Participation in another clinical trial

Where it is running

• King Faissal Specialist Hospital & Research Centre — Riyadh, Saudi Arabia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.