Promotion of a healthy gut microbiome in elective caesarean section arrivals (PROMESA) by supplementing breastfed newborns with an infant probiotic.

Not Applicable

• Conditions: Infant gut microbiome; Digestive System

• Registration Number: ISRCTN11690200
• Lead Sponsor: Evolve BioSystems, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Last Update Posted: 24 October 2022
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Current inclusion criteria as of 17/12/2020:

1. Singleton pregnancies (primip or multi)
2. Pregnant women age 18 and above
3. Elective Caesarean section =37 weeks gestation
4. Maternal pre-pregnancy BMI < 35kg/m²
5. Intention to exclusively breastfeed for at least 35 days, preferably for 6 months
6. Non-smoker (gave up prior to pregnancy)
7. Intention to exclusively breastfeed for at least 3 months
8. Non-smoker (never smoked or gave up prior to enrolment)

_____

Previous inclusion criteria:

1. Singleton pregnancies (primip or multi)
2. Pregnant women age 18 and above
3. Elective Caesarean section =37 weeks gestation
4. Maternal pre-pregnancy BMI < 35kg/m²
5. Resident in UK for 3 years or more
6. Intention to exclusively breastfeed for at least 35 days, preferably for 6 months
7. Non-smoker (gave up prior to pregnancy)

Added 15/07/2020:
8. Willingness to vaccinate infant with BCG vaccine no later than Day 4
9. Intention to exclusively breastfeed for at least 3 months
10. Non-smoker (never smoked or gave up prior to enrolment)

Exclusion Criteria

Current exclusion criteria as of 17/12/2020:

At antenatal screening
1. Multiple pregnancy
2. Vaginal deliveries
3. Fetus has a known medical condition that would preclude breastfeeding or alter gut microbiota
4. Maternal breast surgery or injury within the past 5 years that would reduce the likelihood of successful exclusive breastfeeding (not exclusionary if mother can evidence successful breastfeeding of a previous infant after the surgery or injury)
5. Plan to administer non-study probiotics to infant any time throughout the study
6. Plan to apply maternal vaginal swab to infant’s mouth
7. Maternal infection with HIV or Hepatitis C or experiencing symptoms of COVID-19
8. Maternal smoking (current)
9. Maternal medication use that may alter infant’s gut microbiotia (e.g. daily antibiotics)

At Day 7 postnatal screen, pre-randomization:
1. Infants who have taken antibiotics for more than 3 days
2. Intake of formula within 24 hours of the Postnatal Eligibility Screen
3. Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
4. Mothers who experienced medical complications that would preclude them from breastfeeding
5. Infants who had exposure to maternal vaginal microbiome via oral swab
6. Infants who have received the BCG vaccine
7. Infants whose caregivers intend to vaccinate their infant with the BCG vaccine prior to 3 months of life
8. Infants with known exposure to an individual testing positive for, or experiencing symptoms of, COVID-19

_____

Previous exclusion criteria:

At antenatal screening
1. Multiple pregnancy
2. Recent arrival in UK (< 3 years)
3. Vaginal deliveries
4. Mothers with another child < 14 months of age at recruitment
5. Fetus has a known medical condition that would preclude breastfeeding or alter gut microbiota
6. Maternal breast surgery or injury within the past 5 years that would reduce the likelihood of successful exclusive breastfeeding (not exclusionary if mother can evidence successful breastfeeding of a previous infant after the surgery or injury)
7. Plan to administer non-study probiotics to infant any time throughout the study
8. Plan to apply maternal vaginal swab to infant’s mouth
9. Maternal infection with HIV or Hepatitis C
10. Maternal type 1 or type 2 diabetes (gestational diabetes is not exclusionary)
11. Maternal pre-eclampsia
12. Smoking this pregnancy
13. Plan to leave UK in < 6 months (added 01/08/2019)
14. Maternal medication use that may alter infant’s gut microbiotia (e.g. daily antibiotics) (added 01/08/2019)

At Day 7 postnatal screen, pre-randomization:
1. Infants who have taken antibiotics for more than 3 days
2. Intake of formula within 24 hours of the Day 7-9 visit
3. Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1.The change in infant faecal microbiota before, during and after probiotic or placebo supplementation by shotgun sequencing or next generation sequencing (NGS, e.g. Illumina MISeq or HiSeq)<br><br> Added 01/08/2019:<br> 2. Continuation study: The change in levels of immune cells and markers from baseline (Day 0 – Day 4) to 3 months (Day 84 – Day 104)<br><br> Added 15/07/2020:<br> 3. Extension study: The change in infant faecal B. infantis colonization levels from baseline during B. infantis supplementation as measured by quantitative PCR<br>