FLIP-1 Study V1
Research type
Research Study
Full title
The FLIP-1 Study: Feasibility, safety, tolerance and assessment of LACTIN-V use in a cohort of pregnant women at increased risk of preterm birth.
IRAS ID
262987
Contact name
Phillip Bennett
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
Preterm birth is the primary cause of infant death worldwide. We have demonstrated that a vaginal microbiota dominated by Lactobacillus iners is a risk factor for cervical shortening and/or preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus is protective for these adverse outcomes. A wide range of ‘over the counter’ Lactobacillus spp. containing products, for vaginal administration are available, and are being increasingly used by pregnant women but with no evidence of colonization or benefit.
Our aim is to determine whether vaginal supplementation with Lactobacillus crispatus CTV-05 (LACTIN-V) is associated with colonisation. LACTIN-V has been shown to be safe and acceptable in women treated for bacterial vaginosis and urinary tract infections.
This study will explore colonization efficiency, safety, tolerability, and acceptability of LACTIN-V to women at high risk of preterm birth. This multicentre observational study will be performed at Queen Charlotte’s and Chelsea Hospital and St Mary’s Hospital.
Participants will be offered a course of LACTIN-V. At approximately 14 weeks gestation, subjects will be given a ‘loading phase’ of 5 daily doses of LACTIN-V, followed by a ‘maintenance phase’ of 6 weekly doses, for a total of 11 doses per subject. LACTIN-V is given using a simple self-administered vaginal applicator.
Three mid-vaginal swabs will be taken from the posterior vaginal fornix in combination with a urine sample at 14 weeks, 15 weeks, 18 weeks, between 20-22 weeks and then at 28-30, 34-36 weeks and during labour. A stool sample will be collected in each trimester and blood samples will be collected at 14 weeks, 28-32 weeks, 34-36 weeks and at the onset of labour or pre-elective delivery. A cervical cytobrush sample will be taken in trimester 2 and 3 (14-27 weeks and 28-36 weeks). Women will also be asked to collect cervical-vaginal fluid with a menstrual cup (commonly used to collect menstrual blood, safe to be used in pregnancy) in trimester 2 and 3 (14-27 weeks and 28-36 weeks). At delivery, fetal membranes, placenta, cord blood and first meconium stool will be collected. One meconium sample will be collected 2 weeks post-delivery.
We aim to recruit 60 subjects over a 3 year period.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1018
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion