Infant FormulaNCT06318117
Reason for Prescribing Rice Infant Formula
An observational study of Infant Formula, run by Mead Johnson Nutrition at 17 sites in France.
Trial summary
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Formula
- What is being tested?
- Rice infant formula
- How many people
- 41 participants
- Where
- 17 sitesFrance
- Study dates
- 12 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 120 infants will be recruited for this study, according to the following inclusion and non-inclusion criteria, including at least 60 infants who started the RIF before the age of 6 months.
Who may be able to join
- Child aged between 6 and 36 months,
- Child who has already consumed a RIF for at least one month, or still consuming a RIF, or who will benefit from taking a RIF, according to the pediatrician,
- Legal representatives (parents/guardians) deemed capable of following the requirements of the protocol and have given their consent orally.
Who cannot join
- Child with a clinically relevant and significant abnormality in the medical history or on physical examination;
- Child who has been hospitalized in a neonatology unit (due to prematurity, malformation or neonatal pathology), or born with a low birth weight (≤ 2,500 g);
- For children not diversified at the time of starting RIF: mixed feeding with RIF and breast milk and/or infant formula based on cow's milk;
- Child born to minor parent(s);
- Infant or infant's family unable to comply with study protocol or procedures, in the judgment of the investigator;
- Participation in any other clinical trial prior to inclusion;
- Refusal of the Parents / legal representatives of the child, or who do not master the French language well enough to understand the information letter.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Dr Frederic Couttenier Private Practice
Attiches, 59551
Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department
Auxerre, Auxerre, 89011
Dr Christine REGIMBART - Private Practice
Bécon-les-Granits, Becon-les-Granits, 49026
Elise Foy-Foulkes Private Practice
Boulogne-Billancourt, 92100
Dr. Anne Cheve Private Practice
Brest, 29200
Dr. Sandra Brancato Private Practice
Brignon, 30190
Dr. Karim Abada Private Practice
Foix, 09017
Dr. Nellie Houeto Private Practice
Hyères, 83400
Dr. Anne Sengier - Private Practice
Le Havre, LE Havre, 76600
Dr. Amandine Blasquez Private Practice
Libourne, 33500
Centre Hospitalier de Montauban - Pediatric Department
Montauban, Montauban
Centre Hospitalier Universitaire de Nantes - Pediatric emergency department
Nantes, Nantes, 44093
Dr. Marc Sznajder Private Practice
Paris, 75011
Hôpital NOVO - Pediatric department
Pontoise, Pontoise, 95300
Scm Les Pediatrices Du Pic St Loup
Saint-Clément, DE Riviere, 34980
Dr Marta Nowak-Mohamed - Private Practice
Vichy, Vichy, 03200
Dr. Piotr Gembara Private Practice
Vichy, 03200
About this study
Official title: Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.
Read the detailed description
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.
- Conditions
- Infant Formula
- Being tested
- Rice infant formula
- Keywords
- Rice Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice infant formulaOther
Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.
| Study group | Role | What they receive |
|---|---|---|
| Rice infant formula started before age of 6 months | After inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol.
Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable.
Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall. Receives: Other: Rice infant formula | |
| Rice infant formula started after age of 6 months | After inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol.
Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable.
Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall. Receives: Other: Rice infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire - reason for prescribing a RIF during the 1st year of life.
The main objective is to describe the main reason for prescribing a RIF by the pediatrician during the 1st year of life.
Measured: 1 to 7 months
Secondary outcomes (9)
Questionnaire - Reason for prescribing a RIF in first 6 months of life
- describe the main reason for prescribing a RIF by the pediatrician during the 1st 6 months of life.
Measured: up to 365 days of age
Questionnaire - Diet characteristics
To describe the conditions of RIF consumption during the follow-up, and the other main characteristics of the diet.
Measured: up to 365 days of age
Growth z-scores body mass index (BMI)-for-age
body mass index (BMI)-for-age
Measured: up to 365 days of age
Growth z-score
Weight-for-age z-score
Measured: up to 365 days of age
Growth z-score
Length/Height-for-age z-score
Measured: up to 365 days of age
Growth z-score
Weight-for-length/height z-score
Measured: up to 365 days of age
Growth z-score
Head circumference-for-age z-score
Measured: up to 365 days of age
Questionnaire - Evolution of digestive and allergic symptoms
To describe the evolution of digestive and allergic symptoms during follow-up.
Measured: up to 365 days of age
Socio-demographic characteristics
To describe the socio-demographic characteristics of the infants' families
Measured: up to 365 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 posted19 Mar 2024
- Study start12 Mar 2024
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant FormulaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Hugues Piloquet, MD, Principal investigator, CHU Nantes Children's chronic disease service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318117
- Sponsor's protocol ID
- 3398-1
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions
- ClinicalTrials.gov ID
- NCT06318117
- Acronym / sponsor ID
- 3398-1
- Conditions
- Infant Formula
- Keywords
- Rice Formula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Mar 2024 (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 main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.
Detailed description
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice infant formula started before age of 6 months | – | Other: Rice infant formulaAfter inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol. Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable. Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall. |
| Rice infant formula started after age of 6 months | – | Other: Rice infant formulaAfter inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol. Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable. Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 120 infants will be recruited for this study, according to the following inclusion and non-inclusion criteria, including at least 60 infants who started the RIF before the age of 6 months.
Key inclusion criteria (3 listed)
- Child aged between 6 and 36 months,
- Child who has already consumed a RIF for at least one month, or still consuming a RIF, or who will benefit from taking a RIF, according to the pediatrician,
- Legal representatives (parents/guardians) deemed capable of following the requirements of the protocol and have given their consent orally.
Key exclusion criteria (7 listed)
- Child with a clinically relevant and significant abnormality in the medical history or on physical examination;
- Child who has been hospitalized in a neonatology unit (due to prematurity, malformation or neonatal pathology), or born with a low birth weight (≤ 2,500 g);
- For children not diversified at the time of starting RIF: mixed feeding with RIF and breast milk and/or infant formula based on cow's milk;
- Child born to minor parent(s);
- Infant or infant's family unable to comply with study protocol or procedures, in the judgment of the investigator;
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 infant formulaAny commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume. | Other | Rice infant formula started after age of 6 months, Rice infant formula started before age of 6 months |
Primary outcome
Questionnaire - reason for prescribing a RIF during the 1st year of life.
Time frame: 1 to 7 months
The main objective is to describe the main reason for prescribing a RIF by the pediatrician during the 1st year of life.
9 secondary outcomes
Questionnaire - Reason for prescribing a RIF in first 6 months of life
Time frame: up to 365 days of age
Questionnaire - Diet characteristics
Time frame: up to 365 days of age
Growth z-scores body mass index (BMI)-for-age
Time frame: up to 365 days of age
Growth z-score
Time frame: up to 365 days of age
Growth z-score
Time frame: up to 365 days of age
Growth z-score
Time frame: up to 365 days of age
Growth z-score
Time frame: up to 365 days of age
Questionnaire - Evolution of digestive and allergic symptoms
Time frame: up to 365 days of age
Socio-demographic characteristics
Time frame: up to 365 days of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Infant Formula
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Growth
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
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Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
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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. This study is not recruiting at the moment.
Hugues Piloquet, MD principal investigator
CHU Nantes Children's chronic disease service
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Formula, run by Mead Johnson Nutrition at 17 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire - reason for prescribing a RIF during the 1st year of life. (time frame: 1 to 7 months). 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 30 Jan 2026.