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

January 6, 2026 updated by: Ausnutria Hyproca B.V.

Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faissal Specialist Hospital & Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Goat milk-based infant formula
Other: Goat milk-based infant formula
Study product is administered on demand until the age of 6 months.
Active Comparator: Control group
Cow's milk-based infant formula
Other: Cow's milk-based infant formula
Study product is administered on demand until the age of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms as determined by CoMiSS
Time Frame: Difference between groups at Day 14 of the intervention
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
Time Frame: Difference between groups at the end of the intervention at 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms throughout the study as determined by CoMiSS
Time Frame: From enrollment to the end of the intervention at 24 weeks
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).
From enrollment to the end of the intervention at 24 weeks
Gastrointestinal tolerance throughout the study as determined by IGSQ
Time Frame: From enrollment to the end of the intervention at 24 weeks
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.
From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari
Time Frame: From enrollment to the end of the intervention at 24 weeks
The Vesikari Clinical Severity Scoring System includes a e-diary card completed by parents, to identify rotavirus gastroenteritis episodes. The Vesikari Clinical Severity Scoring System Parameters score ranges from 0 to 20 with score <7 as mild symptoms and score 10 to 20 as severe symptoms.
From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of respiratory infections as determined by CARIFS
Time Frame: From enrollment to the end of the intervention at 24 weeks
Canadian Acute Respiratory Illness and Flu Scale is a validated parental questionnaire, to measure the disease severity of children with acute respiratory illness (ARI) including influenza. CARIFS consists of 18 items covering three domains; symptoms (e.g., cough); function (e.g., play), and parental impact (e.g., clinginess). Each item is scored 0 to 3, with higher scores indicating greater severity of illness. The full scale ranges from 0 to 58. For children older than 5 years the full scale is used; for children younger than 5 years, 3 items (headache, sore throat, and muscle aches) are not used for assessment.
From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of ear infections as determined by AOM-SOS V5
Time Frame: From enrollment to the end of the intervention at 24 weeks
The Acute Otitis Media Symptom Severity scale (AOM-SOS) Version 5.0 is psychometric scale used to measure the severity of symptoms in children with acute otitis media and has been validated for parent-reported use. A 6-point Likert scale ranging from 'No' to 'An extreme amount' is used to rate the presence of 5 symptoms related to acute otitis media over the preceding 24 hours. The AOM-SOS Version 5.0 total score is obtained by summing the scores on these 5 equally-weighted questions.
From enrollment to the end of the intervention at 24 weeks
Quality of life as determined by PedsQL
Time Frame: From enrollment to the end of the intervention at 24 weeks
The Pediatric Quality of Life Inventory (PedsQL™) Infant Scales™ is a specific module of the PedsQL™. The objective of this validated questionnaire is to measure generic health-related quality of life in infants. Applicable for infants with acute and chronic health conditions and healthy infants. The questionnaire is composed of 36 items comprising 5 dimensions: physical functioning, physical symptoms, emotional functioning, social functioning and cognitive functioning. Higher scores means better HRQOL and fewer problems or symptoms. A 5-point Likert scale from is applied: 0 (Never) to 4 (Almost always). Scores are transformed on a scale from 0 to 100.
From enrollment to the end of the intervention at 24 weeks
Quality of life as determined by WHOQoL-BREF
Time Frame: From enrollment to the end of the intervention at 24 weeks
The World Health Organization Quality of Life Questionnaire BREF (WHOQoL-BREF) is the shortened version of the WHOQoL-100. The WHOQoL-BREF measures quality of life within the context of an individual's culture, value systems, personal goals, standards of concerns. The measuring instrument consists of 26 items. The raw scoreis transformed to a 0-100 scale, where higher scores indicate higher perceived quality of life.
From enrollment to the end of the intervention at 24 weeks
Weight
Time Frame: From enrollment to the end of the intervention at 24 weeks
Weight will be measured in kilograms.
From enrollment to the end of the intervention at 24 weeks
Height
Time Frame: From enrollment to the end of the intervention at 24 weeks
Height will be measured in centimeters.
From enrollment to the end of the intervention at 24 weeks
Head circumference
Time Frame: From enrollment to the end of the intervention at 24 weeks
Head circumference will be measured in centimeters.
From enrollment to the end of the intervention at 24 weeks
WHO z-scores
Time Frame: From enrollment to the end of the intervention at 24 weeks
Subject's weight, length and head circumference will be used to calculate the WHO z-scores for weight-for-age, length-for-age, head circumference-for-age, weight-for-length.
From enrollment to the end of the intervention at 24 weeks
Fecal parameters
Time Frame: Baseline, Day 14, Day 28, Week 12 and Week 24
The major fecal bacterial groups are defined using 16S RNA sequencing. Further fecal parameters (e.g. pH, SCFA, sIgA, A1AT) are determined with standard laboratory techniques.
Baseline, Day 14, Day 28, Week 12 and Week 24
Sleep and Crying episodes
Time Frame: Baseline, Day 14, Day 28, Week 12 and Week 24
Sleep and crying episodes and duration are recorded for 24 hours prior to the visits in diaries.
Baseline, Day 14, Day 28, Week 12 and Week 24
Stool frequency & consistenty
Time Frame: Baseline, Day 14, Day 28, Week 12 and Week 24
Stool frequency and consistency are recorded for 24 hours prior to visits in diaries.
Baseline, Day 14, Day 28, Week 12 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ausnutria Hyproca B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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