Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula (NCT07686224) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
156 participantsStarted 2026-06
Plain-language summary
The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk protein-based formula), from their study enrollment until the age of 4 months (postnatal age of 120 days).
The main question it aims to answer is whether daily weight gain of infants fed the experimental formula during the first 4 months of life is non-inferior to that of infants fed the control formula.
Participants are fed exclusively with their assigned formula from enrollment until 120 days of postnatal age.
Parents record any deviation from exclusive feeding with the assigned formula (e.g., intake of solid foods, unauthorized beverages, or any other infant formula).
During the 3 days prior to each study visit (on postnatal days 20, 30, 60, 90, and 120):
* They record all baby bottles consumed by their children
* They assess their child's digestive tolerance of the formula, behavioral parameters, and acceptance of the formula.
They evaluate their child's quality of life at enrollment, and on postnatal days 60 and 120.
Who can participate
Age range
7 Days – 13 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: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 condition…
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
Daily weight gain
Timeframe: From enrollment to the end of intervention at 120 days of age