Healthy Term InfantsRIGANCT07686224
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
A study testing Rice formula (New formula based on hydrolysed rice proteins) in people with Healthy Term Infants, run by Health and Happiness Research Limited at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 13 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Rice formula (New formula based on hydrolysed rice proteins)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Aug 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Private practice - Center 04
Brest
Private Practice - Center 04, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 01
Brignon
Private Practice - Center 01, 0033 6 09 32 35 95, elise.kelner@hh.global
- Not yet recruiting
Private practice - Center 05
Brumath
Private Practice - Center 05, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 09
Charly
Private Practice - Center 09, 0033 6 09 32 35 05, elise.kelner@hh.global
- Recruiting
Private practice - Center 02
Hyères
Private Practice - Center 02, 0033 6 09 32 35 95, elise.kelner@hh.global
- Not yet recruiting
Private practice - Center 03
Libourne
Private Practice - Center 03, MD, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 07
Marseille
Private Practice - Center 07, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 06
Puteaux
Private Practice - Center 06, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 10
Senlis
Private Practice - Center 10, 0033 6 09 32 35 95, elise.kelner@hh.global
- Recruiting
Private practice - Center 08
Vichy
Private Practice - Center 08, 0033 6 09 32 35 95, elise.kelner@hh.global
About this study
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.
Read more
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.
- Conditions
- Healthy Term Infants
- Being tested
- Rice formula (New formula based on hydrolysed rice proteins), Control formula (Standard cow's milk proteins-based formula)
- Keywords
- Growth, Hydrolyzed rice proteins-based formula, Digestive tolerance, Daily weight gain, Anthropometrics, Nutritional adequacy, Healthy term infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)).
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)).
| Study group | Role | What they receive |
|---|---|---|
| Rice formula | Experimental | Hydrolyzed rice proteins-based formula Receives: Other: Rice formula (New formula based on hydrolysed rice proteins) |
| Control formula | Active comparator | Standard cow's milk proteins-based infant formula Receives: Other: Control formula (Standard cow's milk proteins-based formula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily weight gain
Measured: From enrollment to the end of intervention at 120 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start3 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health and Happiness Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vivactis M2Research
- Responsible party
- Sponsor
- Investigators
- Sandra Brancato, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686224
- Sponsor's protocol ID
- RIGA
- Acronym
- RIGA
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
- ClinicalTrials.gov ID
- NCT07686224
- Acronym / sponsor ID
- RIGA / RIGA
- Conditions
- Healthy Term Infants
- Keywords
- Growth, Hydrolyzed rice proteins-based formula, Digestive tolerance, Daily weight gain, Anthropometrics, Nutritional adequacy, Healthy term infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Health and Happiness Research LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Vivactis M2Research
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice formula | Experimental | Other: Rice formula (New formula based on hydrolysed rice proteins)Hydrolyzed rice proteins-based formula |
| Control formula | Active comparator | Other: Control formula (Standard cow's milk proteins-based formula)Standard cow's milk proteins-based infant formula |
Who may qualify
- Ages
- 7 to 13 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice formula (New formula based on hydrolysed rice proteins)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)). | Other | Rice formula |
| Control formula (Standard cow's milk proteins-based formula)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)). | Other | Control formula |
Primary outcome
Daily weight gain
Time frame: From enrollment to the end of intervention at 120 days of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Healthy Term Infants
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Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
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A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
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Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
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Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Infant Nutritional Physiological Phenomena, Infant Formula
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Brancato, MD principal investigator
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice formula (New formula based on hydrolysed rice proteins) in people with Healthy Term Infants, run by Health and Happiness Research Limited at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Kelner (0033 6 09 32 35 95, elise.kelner@hh.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily weight gain (time frame: From enrollment to the end of intervention at 120 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.