Clinical trial NCT06135974: Vaginal lIve Biotherapeutic RANdomized Trial
Official title: Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product
Conditions: Bacterial Vaginosis
Summary: The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question[s] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo.
Participants will:
* be treated with oral antibiotics for BV
* receive 7 days of vaginal study product
* collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment.
Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.
Interventions:
description: Tablet containing at least 2 x 10^6 CFU/tablet, and comprised of 6 strains of Lactobacillus crispatus
name: LC106
type: Drug
description: Tablet containing at least 2 x 10^6 CFU/tablet, and comprised of 15 strains of Lactobacillus crispatus
name: LC115
type: Drug
description: Vaginal tablets containing primarily microcrystalline cellulose and no live bacteria
name: Placebo
type: Drug
description: Metronidazole tablet orally twice daily for 7 days
name: Metronidazole Oral
type: Drug
Study arms:
design_group_description: Vaginal placebo tablet administered daily for 7 days starting after antibiotic treatment
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days after antibiotic treatment
design_group_title: LC106 7 days
design_group_type: Experimental
design_group_description: Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 3 days after antibiotic treatment and packaged with 4 tablets of placebo to maintain masking (so a total of 7 tablets)
design_group_title: LC106 3 days
design_group_type: Experimental
design_group_description: Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days starting on the 3rd day of antibiotic treatment
design_group_title: LC106 7 days, early start
design_group_type: Experimental
design_group_description: Vaginal live biotherapeutic product with 15 strains of L. crispatus, administered daily for 7 days after antibiotic treatment
design_group_title: LC115
design_group_type: Experimental
Sponsor: The Schwartz Center for Compassionate Healthcare
Collaborators: Centre for the AIDS Programme of Research in South Africa
The Ragon Institute of MGH MIT & Harvard
Gates Foundation (United States)
Drug name mappings:
name: LC115(Massachusetts General Hospital)
lang: EN
name: 甲硝唑
lang: CN
name: Metronidazole
lang: EN
name: メトロニダゾール
lang: JP
name: LC106(Massachusetts General Hospital)
lang: EN