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Preterm LaborPhase 1NCT03992534

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

A Phase 1 study testing LACTIN-V in people with Preterm Labor and Preterm Birth, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
LACTIN-V
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
16 Sep 2019to 1 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Phillip Bennett, BSc PhD MD contact

+442075942176

p.bennett@imperial.ac.uk

David MacIntyre, BSc PhD contact

+442075942195

United Kingdom1 site, 1 recruiting

  • Institute of Reproductive Developmental Biology, Hammersmith Hospital

    London, W12 0UQ

    Erna Bayar, MBBS BSc (Hons) MSc FHEA, e.bayar@imperial.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Feasibility, Safety, Tolerance and Assessment of LACTIN-V Use in a Cohort of Pregnant Women at Risk of Preterm Birth

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.

Read the 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.

Being tested
LACTIN-V
Keywords
Pregnancy, Preterm labour, Preterm delivery, Vaginal microbiome, Infection, Next generation sequencing, Lactobacillus
Medical subject headings
Obstetric Labor, Premature, Premature Birth, Preterm Premature Rupture of the Membranes, Uterine Cervical Incompetence, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LACTIN-VCombination product

    Also called Lactobacillus crispatus

    Vaginal supplementation with L. crispatus CTV-05.

Study groups in NCT03992534
Study groupRoleWhat they receive
LACTIN-VExperimentalName 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.
Receives: Combination Product: LACTIN-V

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2-4 years

Secondary outcomes (2)

  1. The number of participants with treatment related adverse events following LACTIN-V supplementation in pregnant women at high risk of preterm birth.

    Participants will be asked about adverse events during clinical review and the safety profile will be recorded.

    Measured: 2-4 years

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

    Clinical outcomes of participants will be analysed, in accordance with colonisation results

    Measured: 2-4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start16 Sep 2019
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03992534
Sponsor's protocol ID
19QC5168
Status last verified
May 2020
First submitted
1 May 2019
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 25758319

  • 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.

    PubMed 29361936

  • 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.

    PubMed 28103952

  • 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.

    PubMed 27488896

  • 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.

    PubMed 21498386

  • 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.

    PubMed 20534435

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LACTIN-V in people with Preterm Labor and Preterm Birth, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Phillip Bennett, BSc PhD MD (+442075942176, p.bennett@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use. (time frame: 2-4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03992534, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.

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