PROMESA

• Research type

  Research Study

• Full title

  PROMESA: Promotion of a healthy gut microbiome in elective caesarean section arrivals

• IRAS ID

  221152

• Contact name

  Rachel Tribe

• Contact email

  rachel.tribe@kcl.ac.uk

• Sponsor organisation

  Evolve BioSystems, Inc.

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  This is a randomized double-blinded placebo-controlled trial of a dietary supplement added to breast milk for enhancement of the normal neonatal gut microbiome in babies delivered by caesarean section. Prior to randomization, women will provide vaginal and rectal swabs for baseline assessment of the maternal microbiome.
  Infants of mothers randomized to B. infantis will receive daily dose for 28 days; controls will receive a placebo. All women will be visited regularly by a research midwife trained in lactation support. Infant faecal samples/swabs will
  be collected and stored at regular intervals during the study until 6 months of age and on three follow-up visits until 2
  years of age.

  The primary outcome is the change in infant fecal B. infantis, Bifidobacterium and microbiota before, during, and after B. infantis supplementation (up to 2 years postnatal).

  Our principal research question is whether short term daily probiotic supplementation (28 days of B. infantis) in breastfed infants delivered by Caesarean section will promote a healthy infant faecal microbiome profile that can be maintained by breastfeeding until weaning at 6 months. The supplement will be added to expressed breast milk once per day.

• REC name

  London - Camberwell St Giles Research Ethics Committee

• REC reference

  17/LO/0641

• Date of REC Opinion

  14 Jul 2017

• REC opinion

  Further Information Favourable Opinion