NCT03992534

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 1, 2019

Last Update Submit

May 26, 2020

Conditions

Preterm LaborPreterm BirthPreterm Premature Rupture of MembraneCervical IncompetenceMiscarriage in Second TrimesterMiscarriage in Third Trimester

Keywords

PregnancyPreterm labourPreterm deliveryVaginal microbiomeInfectionNext generation sequencingLactobacillus

Outcome Measures

Primary Outcomes (1)

  • The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use.

    Microbiological effects of LACTIN-V by laboratory analysis, next generation sequencing

    2-4 years

Secondary Outcomes (2)

  • 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

  • The number of patients using LACTIN-V that go on to experience preterm birth, PPROM or cervical shortening.

    2-4 years

Study Arms (1)

LACTIN-V

EXPERIMENTAL

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.

Combination Product: LACTIN-V

Interventions

LACTIN-VCOMBINATION_PRODUCT

Vaginal supplementation with L. crispatus CTV-05.

Also known as: Lactobacillus crispatus
LACTIN-V

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Reproductive Developmental Biology, Hammersmith Hospital

London, W12 0UQ, United Kingdom

RECRUITING

Related Publications (6)

  • MacIntyre DA, Chandiramani M, Lee YS, Kindinger L, Smith A, Angelopoulos N, Lehne B, Arulkumaran S, Brown R, Teoh TG, Holmes E, Nicoholson JK, Marchesi JR, Bennett PR. The vaginal microbiome during pregnancy and the postpartum period in a European population. Sci Rep. 2015 Mar 11;5:8988. doi: 10.1038/srep08988.

    PMID: 25758319BACKGROUND

  • Brown RG, Marchesi JR, Lee YS, Smith A, Lehne B, Kindinger LM, Terzidou V, Holmes E, Nicholson JK, Bennett PR, MacIntyre DA. Vaginal dysbiosis increases risk of preterm fetal membrane rupture, neonatal sepsis and is exacerbated by erythromycin. BMC Med. 2018 Jan 24;16(1):9. doi: 10.1186/s12916-017-0999-x.

    PMID: 29361936BACKGROUND

  • Kindinger LM, Bennett PR, Lee YS, Marchesi JR, Smith A, Cacciatore S, Holmes E, Nicholson JK, Teoh TG, MacIntyre DA. The interaction between vaginal microbiota, cervical length, and vaginal progesterone treatment for preterm birth risk. Microbiome. 2017 Jan 19;5(1):6. doi: 10.1186/s40168-016-0223-9.

    PMID: 28103952BACKGROUND

  • Kindinger LM, MacIntyre DA, Lee YS, Marchesi JR, Smith A, McDonald JA, Terzidou V, Cook JR, Lees C, Israfil-Bayli F, Faiza Y, Toozs-Hobson P, Slack M, Cacciatore S, Holmes E, Nicholson JK, Teoh TG, Bennett PR. Relationship between vaginal microbial dysbiosis, inflammation, and pregnancy outcomes in cervical cerclage. Sci Transl Med. 2016 Aug 3;8(350):350ra102. doi: 10.1126/scitranslmed.aag1026.

    PMID: 27488896BACKGROUND

  • Stapleton AE, Au-Yeung M, Hooton TM, Fredricks DN, Roberts PL, Czaja CA, Yarova-Yarovaya Y, Fiedler T, Cox M, Stamm WE. Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection. Clin Infect Dis. 2011 May;52(10):1212-7. doi: 10.1093/cid/cir183. Epub 2011 Apr 14.

    PMID: 21498386BACKGROUND

  • Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.

    PMID: 20534435BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature BirthPreterm Premature Rupture of the MembranesUterine Cervical IncompetenceInfections

Interventions

APF protein, Lactobacillus crispatus

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Study Officials

  • Phillip Bennett, BSc PhD MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Bennett, BSc PhD MD

CONTACT

+442075942176p.bennett@imperial.ac.uk

David MacIntyre, BSc PhD

CONTACT

+442075942195

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

June 20, 2019

Study Start

September 16, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available within 6 months of study completion
Access Criteria
as study protocol

Locations

GB(1)