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

Imperial College London

Status and phase: Unknown; Phase 1

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

Treatments: Combination Product: LACTIN-V

Study type: Interventional

Funder types: Other

Identifiers

NCT03992534

19QC5168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

LACTIN-V

Experimental group

Description:

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.

Treatment:

Combination Product: LACTIN-V