Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07686224 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula

Study acronym: RIGA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 9 to 10
  2. Interventions: Control formula (Standard cow's milk proteins-based formula) (Other), Rice formula (New formula based on hydrolysed rice proteins) (Other) to Control formula (Standard cow's milk proteins-based formula) (Other), Rice formula (New formula based on hydrolysed rice proteins) (Other)
    • Eligibility criteria expanded, about 17 words
    • Site details revised at 2 of 9 sites
  3. Recruitment opened
    • Trial sites expanded: 0 → 9 locations
    • Start date changed from estimate of Jun 2026 to Aug 3, 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07686224
Lead Sponsor Health and Happiness Research Limited
Collaborators: Vivactis M2Research
Conditions
(from sponsor)		 Healthy Term Infants
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov