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

Sponsor
Ausnutria Hyproca B.V.
Study ID
NCT07342972
Status
Not Yet Recruiting

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Conditions

  • Anthropometrics
  • Gastrointestinal Symptoms
  • Gastrointestinal Tolerance
  • Infections
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
14 Days - 90 Days
Healthy Volunteers
Accepted

Interventions

  • Goat milk-based infant formula — OTHER
    Study product is administered on demand until the age of 6 months.
  • Cow's milk-based infant formula — OTHER
    Study product is administered on demand until the age of 6 months.

Study Details

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 Dates

First listed
Jan 15, 2026
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Goat milk-based infant formula
  • Active Comparator: Control group
    Cow's milk-based infant formula

Primary Outcome Measure

Gastrointestinal symptoms as determined by CoMiSS [ Time Frame: Difference between groups at Day 14 of the intervention ]

Central Contacts

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