ECOBABe - Early Colonisation with Bacteria After Birth

Not Applicable

• Conditions: Abnormal gut microbiota in infants born by C-section; Metabolic and Endocrine - Metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000339257
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Maternal inclusion criteria:
- greater than or equal to 18 years of age
- delivery at greater than or equal to 37 weeks of gestation

Offspring (CS and vaginal) inclusion criteria:
- APGAR score greater or equal to 7 at 5 minutes after birth

Exclusion Criteria

Maternal exclusion criteria:
- emergency c-section
- multiple pregnancy
- carrying a fetus with chromosomal/single gene defects or syndromes
- type 1 diabetes, type 2 diabetes, or gestational diabetes
- use of probiotic supplements or antibiotics in the last two weeks of pregnancy
- a history suggestive of chorioamnionitis
- premature rupture of membranes (PROM) and prolonged PROM
- intrapartum fever >38°C
- history of genital herpes (CS group only)
- a previous group B streptococcus (GBS)-infected baby
- GBS bacteriuria of any count or a re-occurring GBS infection during the current pregnancy
- any transmissible viral, bacterial, or protozoan pathogens

Offspring exclusion criteria:
- birth before 37 weeks of gestation
- congenital abnormalities detected at birth
- perinatal asphyxia (5-minute Apgar score <7)
- respiratory distress requiring support/oxygen therapy with subsequent admission to NICU
- respiratory distress requiring support/oxygen therapy without NICU admission, but without approval of attending clinician for study inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our primary outcome is a difference in the community structure of the gut microbiota between CS babies who received the active treatment (maternal vaginal microbiota) compared to those who received placebo (sterile water) at 1 month of age. This will be assessed using Bray-Curtis dissimilarity and stastically tested by Permutational Multivariate Analysis of Variance (PERMANOVA).[1 month of age]