Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula (MESK-2)

Ausnutria Hyproca

Status: Not yet enrolling

Conditions: Quality of Life; Anthropometrics; Infections; Gastrointestinal Symptoms; Gastrointestinal Tolerance

Treatments: Other: Goat milk-based infant formula; Other: Cow's milk-based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT07342972

P24-150

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 14 to 90 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

144 participants in 2 patient groups

Intervention group

Experimental group

Description:

Goat milk-based infant formula

Treatment:

Other: Goat milk-based infant formula

Control group

Active Comparator group

Description:

Cow's milk-based infant formula

Treatment:

Other: Cow's milk-based infant formula