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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Tolerance Gastrointestinal Symptoms Infections Quality of Life Anthropometrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, double-blind clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Goat milk-based infant formula

Group Type EXPERIMENTAL

Goat milk-based infant formula

Intervention Type OTHER

Study product is administered on demand until the age of 6 months.

Control group

Cow's milk-based infant formula

Group Type ACTIVE_COMPARATOR

Cow's milk-based infant formula

Intervention Type OTHER

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.

Intervention Type OTHER

Cow's milk-based infant formula

Study product is administered on demand until the age of 6 months.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King Faissal Specialist Hospital & Research Centre

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Jildou Visser, BSc

Role: CONTACT

+31885015283

Facility Contacts

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Abdullah Aldowaish, Dr.

Role: primary

0555878540

Other Identifiers

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P24-150

Identifier Type: -

Identifier Source: org_study_id

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