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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sofia Nordh, PhD
- Telefonnummer: +46 (0)8 555 293 00
- E-post: son@biogaianewsciences.com
Studiesteder
-
-
-
Helsinki, Finland
- Helsinki University Hospital
-
Ta kontakt med:
- Samuli Rautava, MD
-
Tampere, Finland
- Tampere University Hospital
-
Ta kontakt med:
- Sauli Palmu, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Probiotic+ Vitamin D3
C-section, active group
|
Probiotic+vitamin D3 drops
|
|
Placebo komparator: Placebo+ Vitamin D3
C-section, placebo group
|
Placebo+vitamin D3
|
|
Placebo komparator: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
|
Placebo+vitamin D3
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
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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.
|
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CSUB0198
Plan for individuelle deltakerdata (IPD)
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