Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula (RIGA)
25. august 2026 opdateret af: Health and Happiness Research Limited
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
156
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Elise Kelner
- Telefonnummer: 0033 6 09 32 35 95
- E-mail: elise.kelner@hh.global
Studiesteder
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Brest, Frankrig, 29200
- Ikke rekrutterer endnu
- Private practice - Dr. Chevé
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Kontakt:
- Anne Chevé, MD
- Telefonnummer: 0033 2 98 30 58 90
- E-mail: dr.anne.cheve@wanadoo.fr
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Ledende efterforsker:
- Anne Chevé, MD
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Brignon, Frankrig, 30190
- Ikke rekrutterer endnu
- Private practice - Dr. Brancato
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Kontakt:
- Sandra Brancato, MD
- Telefonnummer: 0033 7 63 92 35 45
- E-mail: dr.sandra.brancato@gmail.com
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Ledende efterforsker:
- Sandra Brancato, MD
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Brumath, Frankrig, 67170
- Ikke rekrutterer endnu
- Private practice - Dr. Delobbe
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Kontakt:
- Jean-François Delobbe, MD
- Telefonnummer: 0033 3 69 31 61 54
- E-mail: delobbejf@yahoo.fr
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Ledende efterforsker:
- Jean-François Delobbe, MD
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Charly, Frankrig, 69390
- Ikke rekrutterer endnu
- Private practice - Dr. Béguin
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Kontakt:
- Anne Béguin, MD
- Telefonnummer: 0033 6 20 63 84 52
- E-mail: anneverrierbeguin@gmail.com
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Ledende efterforsker:
- Anne Béguin, MD
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Hyères, Frankrig, 83400
- Rekruttering
- Private practice - Dr. Houeto
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Kontakt:
- Nellie Houeto, MD
- Telefonnummer: 0033 4 94 31 82 25
- E-mail: nellie.houeto.pediatre@gmail.com
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Ledende efterforsker:
- Nellie Houeto, MD
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Libourne, Frankrig, 35500
- Ikke rekrutterer endnu
- Private practice - Dr. Blasquez
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Kontakt:
- Amandine Blasquez, MD
- Telefonnummer: 0033 5 33 03 09 10
- E-mail: 0630102704@orange.fr
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Ledende efterforsker:
- Amandine Blasquez, MD
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Marseille, Frankrig, 13009
- Ikke rekrutterer endnu
- Private practice - Dr. Dumont
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Kontakt:
- Mylène Dumont, MD
- Telefonnummer: 0033 4 91 41 87 72
- E-mail: mylne_dumont@yahoo.fr
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Ledende efterforsker:
- Mylène Dumont, MD
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Senlis, Frankrig, 60300
- Rekruttering
- Private practice - Dr. Achkar-Helou
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Kontakt:
- Myrna Achkar-Helou, MD
- Telefonnummer: 0033 621551508
- E-mail: heloumirna@hotmail.com
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Ledende efterforsker:
- Myrna Achkar-Helou, MD
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Vichy, Frankrig, 03200
- Ikke rekrutterer endnu
- Private practice - Dr. Gembara
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Kontakt:
- Piotr Gembara, MD
- Telefonnummer: 0033 4 70 31 11 23
- E-mail: dr.piotr.gembara@wanadoo.fr
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Ledende efterforsker:
- Piotr Gembara, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Rice formula
Hydrolyzed rice proteins-based formula
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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)).
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Aktiv komparator: Control formula
Standard cow's milk proteins-based infant formula
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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)).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Daily weight gain
Tidsramme: From enrollment to the end of intervention at 120 days of age
|
From enrollment to the end of intervention at 120 days of age
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sandra Brancato, MD
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2026
Primær færdiggørelse (Anslået)
1. februar 2028
Studieafslutning (Anslået)
1. februar 2028
Datoer for studieregistrering
Først indsendt
30. juni 2026
Først indsendt, der opfyldte QC-kriterier
30. juni 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RIGA
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .