Infant Formula Study With Pre- And Postbiotics
26. august 2026 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Cork, Irland
- Atlantia Food Clinical Trials
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Catherine Stanton, Teagasc
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. juni 2021
Primær fullføring (Faktiske)
18. oktober 2023
Studiet fullført (Faktiske)
18. oktober 2023
Datoer for studieregistrering
Først innsendt
17. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juli 2026
Først lagt ut (Faktiske)
29. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AFCRO-123
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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