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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Labor Preterm Birth Preterm Premature Rupture of Membrane Cervical Incompetence Miscarriage in Second Trimester Miscarriage in Third Trimester

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LACTIN-V

Intervention Type COMBINATION_PRODUCT

Vaginal supplementation with L. crispatus CTV-05.

Interventions

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LACTIN-V

Vaginal supplementation with L. crispatus CTV-05.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Lactobacillus crispatus

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No