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Goat milk formula may soothe baby digestion better than Cow's milk

NCT ID NCT07342972

Symptom relief Sponsor: Ausnutria Hyproca B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will compare a goat milk-based infant formula to a standard cow milk formula in 144 healthy babies aged 2 weeks to 3 months. Researchers will track digestive symptoms like crying, spit-up, and stool patterns using special scoring tools. The goal is to see if goat milk formula leads to fewer tummy troubles and better overall tolerance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goat milk-based infant formula
What this could lead to
If it works, this could show that goat milk formula is a gentler option for babies with mild digestive discomfort.
What could go wrong
This is a small, early-stage trial with no phase designation, so results may not be conclusive. The formula is not a treatment for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 90 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Infections infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anthropometrics Gastrointestinal symptoms Gastrointestinal tolerance Infections Quality of life

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • King Faissal Specialist Hospital & Research Centre

    Riyadh, Saudi Arabia

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Other studies related to the condition(s) this trial covers.