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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACTIN-V | Combination Product | Vaginal supplementation with L. crispatus CTV-05. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-4 years |
| The number of patients using LACTIN-V that go on to experience preterm birth, PPROM or cervical shortening. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phillip Bennett, BSc PhD MD | Contact | +442075942176 | p.bennett@imperial.ac.uk | |
| David MacIntyre, BSc PhD | Contact | +442075942195 |
| Name | Affiliation | Role |
|---|---|---|
| Phillip Bennett, BSc PhD MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Reproductive Developmental Biology, Hammersmith Hospital | Recruiting | London | W12 0UQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25758319 | Background | 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. | |
| 29361936 | Background |
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Data will be available within 6 months of study completion
as study protocol
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Clinical outcomes of participants will be analysed, in accordance with colonisation results |
| 2-4 years |
| 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. |
| 28103952 | Background | 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. |
| 27488896 | Background | 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. |
| 21498386 | Background | 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. |
| 20534435 | Background | 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. |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D047928 | Premature Birth |
| C563032 | Preterm Premature Rupture of the Membranes |
| D002581 | Uterine Cervical Incompetence |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C494788 | APF protein, Lactobacillus crispatus |
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