NCT07686224

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Feb 2028

Study Start

First participant enrolled

June 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Healthy Term Infants

Keywords

GrowthHydrolyzed rice proteins-based formulaDigestive toleranceDaily weight gainAnthropometricsNutritional adequacyHealthy term infants

Outcome Measures

Primary Outcomes (1)

  • Daily weight gain

    From enrollment to the end of intervention at 120 days of age

Study Arms (2)

Rice formula

EXPERIMENTAL

Hydrolyzed rice proteins-based formula

Other: Rice formula (New formula based on hydrolysed rice proteins)

Control formula

ACTIVE COMPARATOR

Standard cow's milk proteins-based infant formula

Other: Control formula (Standard cow's milk proteins-based formula)

Interventions

Rice formula (New formula based on hydrolysed rice proteins)OTHER

The infant is exclusively fed the infant formula based on hydrolysed rice proteins from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)).

Rice formula
Control formula (Standard cow's milk proteins-based formula)OTHER

The infant is exclusively fed the control formula from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)).

Control formula

Eligibility Criteria

Age7 Days - 13 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 7, 2026

Record last verified: 2026-06