Influence of Probiotics on Early Gut Microbial Colonization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic drops, Placebo drops.
- Who it may be relevant to
- Registry conditions: C-Section. Basic parameters: 0 Days — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
Overview
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.
Interventions
- Dietary supplement Probiotic drops
Probiotic+vitamin D3 drops - Dietary supplement Placebo drops
Placebo+vitamin D3
Primary outcome measures
- To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls. [Time frame: week 2]
Secondary outcome measures (11)
- To evaluate the gut microbiome colonization and composition. [Time frame: week 2]
- To evaluate the gut microbiome colonization and composition. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.]
- To assess quality of life [Time frame: Weeks 4 and 8, with optional assessments at 6 and 12 months.]
- To assess quality of life. [Time frame: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.]
- To assess quality of life [Time frame: Weeks 4 and 8, with optional assessments at 6 and 12 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Finland · 2 centers
- Helsinki University Hospital — Helsinki
- Tampere University Hospital — Tampere
Identifiers
NCT: NCT07608341 · CSUB0198