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

NCT07342972 | Not Yet Recruiting

• 1 other identifier: P24-150
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Formula; Infant; Goat milk-based infant formula; RCT; Gastrointestinal symptoms; Gastrointestinal tolerance

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal symptoms as determined by CoMiSS

  The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms).

  Difference between groups at Day 14 of the intervention

• Gastrointestinal tolerance as determined by IGSQ

  The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress.

  Difference between groups at the end of the intervention at 24 weeks

Secondary Outcomes (14)

• Gastrointestinal symptoms throughout the study as determined by CoMiSS

  From enrollment to the end of the intervention at 24 weeks

• Gastrointestinal tolerance throughout the study as determined by IGSQ

  From enrollment to the end of the intervention at 24 weeks

• Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari

  From enrollment to the end of the intervention at 24 weeks

• Occurrence, duration and severity of respiratory infections as determined by CARIFS

  From enrollment to the end of the intervention at 24 weeks

• Occurrence, duration and severity of ear infections as determined by AOM-SOS V5

  From enrollment to the end of the intervention at 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Goat milk-based infant formula

Other: Goat milk-based infant formula

Control group

ACTIVE COMPARATOR

Cow's milk-based infant formula

Other: Cow's milk-based infant formula

Interventions

Goat milk-based infant formula OTHER

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

Intervention group

Cow's milk-based infant formula OTHER

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

Control group

Eligibility Criteria

• Age: 14 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Ausnutria Hyproca B.V.: lead

Study Sites (1)

King Faissal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Infections

Central Study Contacts

Jildou Visser, BSc

CONTACT

+31885015283; nutrition.support@ausnutria.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, double-blind clinical trial

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)