DIVINE Study

• Research type

  Research Study

• Full title

  Influence of Periconceptional Dietary Habits on Digestive and Vaginal Microbiome and Their Impact on Birth Outcomes -Feasibility Study

• IRAS ID

  362305

• Contact name

  Megumi Nimura

• Contact email

  m.nimura@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  1 years, 5 months, 30 days

• Research summary

  DESIGN: Prospective cohort study

  AIM:
  To assess the feasibility and acceptability of the study method investigating how periconceptional dietary habits influence the gut and vaginal microbiomes, and how these are associated with pregnancy outcomes (term birth, miscarriage, preterm birth) and complications across the first to third trimesters.

  OUTCOME MEASURES:
  The primary outcomes are feasibility and acceptability of recruitment, sample collection (urine, vaginal, rectal, stool), dietary assessment tools (SFFFQ, FFQ, Food diary), and laboratory processing.
  Secondary outcomes include preliminary associations between diet, microbiome profiles, urinary biomarkers, vaginal inflammatory profile, and pregnancy outcomes, as well as data quality to inform future study design.

  POPULATION:
  Pregnant women attending Early Pregnancy Assessment Unit (EPAU) and Antenatal Clinic (ANC) at Queen Charlotte and Chelsea Hospital (QCCH), St Mary’s Hospital (SMH), Imperial College NHS Healthcare Trust (ICHT), London.

  ELIGIBILITY:
  -Pregnant women ≥18 years old
  -Gestational age ≤ 13+6 weeks
  -Planned delivery at QCCH or St Mary’s Hospital

  DATA AND SAMPLE COLLECTION:
  -Food Frequency Questionnaire (FFQ) OR Short Form Food Frequency Questionnaire (SFFFQ)
  -Online food diary (Libro)
  -Urine Sample
  -Vaginal swabs
  -Rectal swab
  -Stool sample
  -Sociodemographic information and medical history
  -Pregnancy outcomes and complications
  -Participant Acceptability Questionnaire

  DURATION: 18 months, commencing January 2026

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  25/YH/0274

• Date of REC Opinion

  20 Jan 2026

• REC opinion

  Further Information Favourable Opinion