Influence of Probiotics on Early Gut Microbial Colonization (STORKIE)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sofia Nordh, PhD
- Telefoonnummer: +46 (0)8 555 293 00
- E-mail: son@biogaianewsciences.com
Studie Locaties
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Helsinki, Finland
- Helsinki University Hospital
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Contact:
- Samuli Rautava, MD
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Tampere, Finland
- Tampere University Hospital
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Contact:
- Sauli Palmu, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Probiotic+ Vitamin D3
C-section, active group
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Probiotic+vitamin D3 drops
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Placebo-vergelijker: Placebo+ Vitamin D3
C-section, placebo group
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Placebo+vitamin D3
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Placebo-vergelijker: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
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Placebo+vitamin D3
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
Tijdsspanne: week 2
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To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
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week 2
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: week 2
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To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
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week 2
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the faecal relative abundance and composition of Actinobacteria over time
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: 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.
Tijdsspanne: 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
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: 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
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate faecal relative abundance and composition of Bacillota over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: 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
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
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To evaluate the gut microbiome colonization and composition.
Tijdsspanne: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To assess quality of life
Tijdsspanne: Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To assess quality of life.
Tijdsspanne: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
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To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
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Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
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To assess quality of life
Tijdsspanne: Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CSUB0198
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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