Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Influence of Probiotics on Early Gut Microbial Colonization (STORKIE)

19. maj 2026 opdateret af: BioGaia AB

Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section

The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.

An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.

Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Finland
      • Helsinki, Finland
        • Helsinki university hospital
        • Kontakt:
          • Samuli Rautava, MD
      • Tampere, Finland
        • Tampere University Hospital
        • Kontakt:
          • Sauli Palmu, MD

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:

Infant born by planned C-section or vaginal born infant

Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks

Infant Apgar score 7-10, (5 minutes after birth)

Intention to breastfeed the infant

Parents/legal guardians are >18 years

Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples

Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator

Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study

Exclusion Criteria:

>72 hours after birth when collecting the first faecal sample and given the first drops of study product

Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.

Infants with birth of congenital malformations or anomalies

Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)

Infants requiring care in neonatal unit

Disruption of amniotic membranes for >24 hours

Infants consuming probiotics, including in infant formula

Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery

Participation in other clinical studies

Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Probiotic+ Vitamin D3
C-section, active group
Kosttilskud: Probiotic drops
Probiotic+vitamin D3 drops
Placebo komparator: Placebo+ Vitamin D3
C-section, placebo group
Kosttilskud: Placebo drops
Placebo+vitamin D3
Placebo komparator: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
Kosttilskud: Placebo drops
Placebo+vitamin D3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
Tidsramme: week 2
To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
week 2

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the gut microbiome colonization and composition.
Tidsramme: week 2
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
week 2
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the faecal relative abundance and composition of Actinobacteria over time
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the faecal relative abundance of Bifidobacterium over time
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate faecal relative abundance and composition of Proteobacteria over time
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate faecal relative abundance and composition of Enterobacteriaceae over time
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To evaluate faecal relative abundance and composition of Bacillota over time
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Tidsramme: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To assess quality of life
Tidsramme: Weeks 4 and 8, with optional assessments at 6 and 12 months.
To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
Weeks 4 and 8, with optional assessments at 6 and 12 months.
To assess quality of life.
Tidsramme: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
To assess quality of life
Tidsramme: Weeks 4 and 8, with optional assessments at 6 and 12 months.
To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
Weeks 4 and 8, with optional assessments at 6 and 12 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BioGaia AB

Samarbejdspartnere

Aurevia

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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2030

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CSUB0198

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med C-sektion

Kliniske forsøg med Probiotic drops

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner