Infant Formula Study With Pre- And Postbiotics
26. august 2026 opdateret af: Nutricia UK Ltd
Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period.
Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition.
The primary objective is to assess gastrointestinal tolerance and safety.
Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome.
The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cork, Irland
- Atlantia Food Clinical Trials
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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:
- Parent's or legal guardian's aged 18 years, written informed consent.
- Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
- Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
- Healthy term singleton infants, gestational age ~ 37 and < 42 weeks (i.e.,~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist.
- Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
- Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded.
Exclusion criteria:
- Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor.
- Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Investigator's uncertainty about the willingness or ability of the parents/legal guardians to 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: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Infant formula
24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation
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Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gastrointestinal Tolerance - Stool consistency and frequency
Tidsramme: 24 weeks
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Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Weight)
Tidsramme: 24 weeks
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Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Length)
Tidsramme: 24 weeks
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Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Head circumference)
Tidsramme: 24 weeks
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Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Adverse Events
Tidsramme: 24 weeks
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Occurrence of (serious) AE measured throughout the intervention period.
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24 weeks
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Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)
Tidsramme: 24 weeks
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Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems.
PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
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24 weeks
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Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
Tidsramme: 24 weeks
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The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress.
IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
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24 weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Exploratory parameter - Gut Microbiota
Tidsramme: 24 weeks
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Characterisation of the gut microbiota composition and functionality of infants consuming the study product at baseline and week 2, week 10, and week 24 using metagenomics and culturomics sequencing methods.
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24 weeks
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Exploratory parameter - Parent's Product Acceptability
Tidsramme: 24 weeks
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To assess acceptability of the study product at baseline and week 2, week 10, and week 24 using a product evaluation questionnaire.
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24 weeks
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Exploratory parameter - Comparison with INFANTMET study
Tidsramme: 24 weeks
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Comparison of gut microbiota composition and functionality with an external reference cohort of exclusively breastfed infants from the INFANTMET study.
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24 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Catherine Stanton, Teagasc
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)
17. juni 2021
Primær færdiggørelse (Faktiske)
18. oktober 2023
Studieafslutning (Faktiske)
18. oktober 2023
Datoer for studieregistrering
Først indsendt
17. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juli 2026
Først opslået (Faktiske)
29. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AFCRO-123
Plan for individuelle deltagerdata (IPD)
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