Growth of healthy term infants fed a hydrolysed rice protein formula vs cow's milk formula

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two infant formulas in healthy term babies from enrollment (7-13 days old) to 120 days of age. Infants are exclusively fed the assigned formula, with parental logs to track feeding and digestive tolerance. Primary aim is to determine non-inferiority of daily weight gain with the hydrolysed rice protein formula versus a standard cow's milk protein formula over the first 4 months. Follow-up visits occur at 20, 30, 60, 90, and 120 days, during which feeding is reviewed and growth and tolerance are assessed. The study is conducted by Health and Happiness Research Limited with collaboration from Vivactis M2Research at multiple private centers in France.

Why it matters

Who can join: the full rules

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.

Where it's running

• Private practice - Center 01
  Brignon, France Recruiting
• Private practice - Center 09
  Charly, France Recruiting
• Private practice - Center 02
  Hyères, France Recruiting
• Private practice - Center 07
  Marseille, France Recruiting
• Private practice - Center 06
  Puteaux, France Recruiting
• Private practice - Center 10
  Senlis, France Recruiting

Study contacts

• Principal investigator: Sandra Brancato, MD
• Study coordinator: Elise Kelner
• Email: elise.kelner@hh.global
• Phone: 0033 6 09 32 35 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.