Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula (NCT07342972) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
Saudi Arabia144 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
14 Days – 90 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastrointestinal symptoms as determined by CoMiSS
Timeframe: Difference between groups at Day 14 of the intervention
2
Gastrointestinal tolerance as determined by IGSQ
Timeframe: Difference between groups at the end of the intervention at 24 weeks