The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth

Phase 1

• Conditions: Miscarriage in Third Trimester; Preterm Birth; Miscarriage in Second Trimester; Preterm Labor; Preterm Premature Rupture of Membrane; Cervical Incompetence
• Interventions: Combination Product: LACTIN-V

• Registration Number: NCT03992534
• Lead Sponsor: Imperial College London

Brief Summary

Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

Detailed Description

Pregnant women at Queen Charlotte's and Chelsea Hospital and St Mary's Hospital London who are defined as being at a higher than background risk for preterm labour will be recruited into this study. Women at risk of pre-term labour will include those with either previous LLETZ, previous preterm birth, previous second trimester pregnancy loss or a combination of these indications.

As part of this interventional study, subjects will be offered supplementation with L. crispatus CTV-05. The preparation of LACTIN-V is administered vaginally using a specially designed applicator.

The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2019-09-16
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women at risk of preterm labour
• Women referred to the prematurity clinic
• Women with previous LLETZ (large loop excision of the transformation zone)
• Women with previous preterm birth
• Women with previous second trimester loss

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Exclusion Criteria

• HIV positive women
• Women who are unable to provide informed consent
• Women aged <18
• Women receiving antibiotic treatment within 1 week of recruitment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LACTIN-V	LACTIN-V	Name of Product: LACTIN-V (Lactobacillus crispatus CTV-05) Dosage: LACTINV is a powder formulation of Lactobacillus crispatus CTV-05 provided in a prefilled vaginal applicator at a dose of 2 x 10\^9 CFU of L. crispatus CTV-05. Route of Administration: LACTIN-V powder is administered vaginally using a specially designed applicator. Formulation: LACTIN-V is supplied as a pre-filled, single-use applicator. Each applicator contains LACTIN-V powder at a dose of 2 x 10\^9 CFU. The LACTIN-V powder formulation contains L. crispatus CTV-05 and a preservation matrix containing inactive excipients of non-animal origin.

Primary Outcome Measures

Name	Time	Method
The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use.	2-4 years	Microbiological effects of LACTIN-V by laboratory analysis, next generation sequencing

Secondary Outcome Measures

Name	Time	Method
The number of participants with treatment related adverse events following LACTIN-V supplementation in pregnant women at high risk of preterm birth.	2-4 years	Participants will be asked about adverse events during clinical review and the safety profile will be recorded.
The number of patients using LACTIN-V that go on to experience preterm birth, PPROM or cervical shortening.	2-4 years	Clinical outcomes of participants will be analysed, in accordance with colonisation results

Trial Locations

Locations (1)

Institute of Reproductive Developmental Biology, Hammersmith Hospital; 🇬🇧 London, United Kingdom