Gastrointestinal ToleranceMESK-2NCT07342972
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
A study testing Goat milk-based infant formula and Cow's milk-based infant formula in people with Gastrointestinal Tolerance and Gastrointestinal Symptoms, run by Ausnutria Hyproca B.V. at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections
- What is being tested?
- Goat milk-based infant formula and Cow's milk-based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Faissal Specialist Hospital & Research Centre
Riyadh
Abdullah Aldowaish, Dr., 0555878540, dowaish@kfshrc.edu.sa
About this study
Official title: 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.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life, Anthropometrics
- Being tested
- Goat milk-based infant formula, Cow's milk-based infant formula
- Keywords
- Formula, Infant, Goat milk-based infant formula, RCT, Gastrointestinal symptoms, Gastrointestinal tolerance
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goat milk-based infant formulaOther
Study product is administered on demand until the age of 6 months.
Cow's milk-based infant formulaOther
Study product is administered on demand until the age of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Goat milk-based infant formula Receives: Other: Goat milk-based infant formula |
| Control group | Active comparator | Cow's milk-based infant formula Receives: Other: Cow's milk-based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Difference between groups at the end of the intervention at 24 weeks
Secondary outcomes (14)
Gastrointestinal symptoms throughout the study 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).
Measured: From enrollment to the end of the intervention at 24 weeks
Gastrointestinal tolerance throughout the study 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.
Measured: From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of respiratory infections as determined by CARIFS
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Occurrence, duration and severity of ear infections as determined by AOM-SOS V5
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Quality of life as determined by PedsQL
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Quality of life as determined by WHOQoL-BREF
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Weight
Weight will be measured in kilograms.
Measured: From enrollment to the end of the intervention at 24 weeks
Height
Height will be measured in centimeters.
Measured: From enrollment to the end of the intervention at 24 weeks
Head circumference
Head circumference will be measured in centimeters.
Measured: From enrollment to the end of the intervention at 24 weeks
WHO z-scores
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.
Measured: From enrollment to the end of the intervention at 24 weeks
Fecal parameters
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.
Measured: Baseline, Day 14, Day 28, Week 12 and Week 24
Sleep and Crying episodes
Sleep and crying episodes and duration are recorded for 24 hours prior to the visits in diaries.
Measured: Baseline, Day 14, Day 28, Week 12 and Week 24
Stool frequency & consistenty
Stool frequency and consistency are recorded for 24 hours prior to visits in diaries.
Measured: Baseline, Day 14, Day 28, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, double-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342972
- Sponsor's protocol ID
- P24-150
- Acronym
- MESK-2
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07342972
- Acronym / sponsor ID
- MESK-2 / P24-150
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life, Anthropometrics
- Keywords
- Formula, Infant, Goat milk-based infant formula, RCT, Gastrointestinal symptoms, Gastrointestinal tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Goat milk-based infant formulaGoat milk-based infant formula |
| Control group | Active comparator | Other: Cow's milk-based infant formulaCow's milk-based infant formula |
Who may qualify
- Ages
- 14 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goat milk-based infant formulaStudy product is administered on demand until the age of 6 months. | Other | Intervention group |
| Cow's milk-based infant formulaStudy product is administered on demand until the age of 6 months. | Other | Control group |
Primary outcome
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).
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.
14 secondary outcomes
Gastrointestinal symptoms throughout the study as determined by CoMiSS
Time frame: 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
Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari
Time frame: 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
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
Quality of life as determined by PedsQL
Time frame: 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
Weight
Time frame: 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
Head circumference
Time frame: 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
Fecal parameters
Time frame: 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
Stool frequency & consistenty
Time frame: Baseline, Day 14, Day 28, Week 12 and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goat milk-based infant formula and Cow's milk-based infant formula in people with Gastrointestinal Tolerance and Gastrointestinal Symptoms, run by Ausnutria Hyproca B.V. at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jildou Visser, BSc (+31885015283, nutrition.support@ausnutria.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms as determined by CoMiSS (time frame: Difference between groups at Day 14 of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.