Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
NCT ID: NCT07342972
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
144 participants
INTERVENTIONAL
2026-02-28
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention group
Goat milk-based infant formula
Goat milk-based infant formula
Study product is administered on demand until the age of 6 months.
Control group
Cow's milk-based infant formula
Cow's milk-based infant formula
Study product is administered on demand until the age of 6 months.
Interventions
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Goat milk-based infant formula
Study product is administered on demand until the age of 6 months.
Cow's milk-based infant formula
Study product is administered on demand until the age of 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Days
90 Days
ALL
Yes
Sponsors
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Ausnutria Hyproca B.V.
INDUSTRY
Responsible Party
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Locations
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King Faissal Specialist Hospital & Research Centre
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P24-150
Identifier Type: -
Identifier Source: org_study_id
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