C-Section
Conditions
Keywords
microbiome, c-section, probiotic, gut microbiome
Brief summary
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_SUPPLEMENTProbiotic drops
Probiotic+vitamin D3 drops
DIETARY_SUPPLEMENTPlacebo drops
Placebo+vitamin D3
Sponsors
BioGaia AB
Aurevia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 3 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls. | week 2 | To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the gut microbiome colonization and composition. | week 2 | To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome |
| To assess quality of life | Weeks 4 and 8, with optional assessments at 6 and 12 months. | To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL), |
| To assess quality of life. | 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) |
Countries
Finland
Contacts
CONTACTSofia Nordh, PhD
Outcome results
None listed