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Rice formula could rival Cow's milk for baby growth

NCT ID NCT07686224

Disease control Sponsor: Health and Happiness Research Limited Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study tests whether a new infant formula made from hydrolysed rice protein supports healthy growth as well as standard cow's milk formula. Healthy full-term babies are fed exclusively one of the two formulas from about 10 days old until 4 months of age. Researchers track daily weight gain and other growth measures to see if the rice formula is a suitable alternative.

What this could mean

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

Active substance
hydrolysed rice protein-based infant formula
What this could lead to
If successful, this could offer a nutritious alternative to cow's milk formula for infants with allergies or dietary preferences.
What could go wrong
This is a small, early-stage trial focused on growth non-inferiority, not safety or long-term outcomes. The rice formula may not match all nutritional benefits of standard formula.

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 156 people

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

Started

Aug 2026

Expected to finish

Feb 2028

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

7 to 13 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:Should be included healthy term infants: * with a gestational age comprised between 37 and 42 weeks * with an adequate weight for gestational age at birth (weight birth comprised between the 10th and 90th percentiles of French Audipog growth charts) * aged between 7 and 13 days at time of enrolment * from singleton pregnancies * whose mothers, prior to inclusion in the study, had independently opted for exclusive formula feeding * exclusively fed with infant formula for at least 5 days prior to enrolment * whose both parents/legal representative(s) agreed to participate in the study by signing written informed consents * whose at least one parent/legal representative is beneficiary of a social security scheme according to the local regulations. Exclusion Criteria: Should not be included: * infants with significant prenatal disease or anatomic or physiologic conditions or use of medications that would interfere with normal growth, development, or feeding * infants with hospitalization within the first 2 weeks of life after leaving the maternity ward except for hyperbilirubinemia * infants with suspected or diagnosed cow's milk allergy or any other known or suspected food intolerance/allergy (lactose, fish, soy …) * infants with special dietary needs, feeding difficulties * infants with antibiotic use before inclusion * infants participating or having participated in another clinical trial since their birth. * infants born to mothers with medical conditions that could interfere on the infant's gastrointestinal tract/ability to be fed and/or growth (e.g., eclampsia, insulin-dependent diabetes mellitus) * infants whose mothers used illicit drugs or alcohol during their pregnancy * infants whose parents cannot comply with the protocol requirements.

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As listed by the trial registrant

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

Healthy term infants

How to take part

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

  1. The places running it

    9 sites. 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

  • Private practice - Dr. Achkar-Helou

    RECRUITING

    Senlis, 60300, France

  • Private practice - Dr. Blasquez

    NOT_YET_RECRUITING

    Libourne, 35500, France

  • Private practice - Dr. Brancato

    NOT_YET_RECRUITING

    Brignon, 30190, France

  • Private practice - Dr. Béguin

    NOT_YET_RECRUITING

    Charly, 69390, France

  • Private practice - Dr. Chevé

    NOT_YET_RECRUITING

    Brest, 29200, France

  • Private practice - Dr. Delobbe

    NOT_YET_RECRUITING

    Brumath, 67170, France

  • Private practice - Dr. Dumont

    NOT_YET_RECRUITING

    Marseille, 13009, France

  • Private practice - Dr. Gembara

    NOT_YET_RECRUITING

    Vichy, 03200, France

  • Private practice - Dr. Houeto

    RECRUITING

    Hyères, 83400, France