Vaginal lIve Biotherapeutic RANdomized Trial

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.

Timeline

Start

2024-02-01

Primary completion

2024-12-26

Completion

2025-02-18

Publications

• Milford C, Dlamini BL, Mafunda NA, Hardwick TS, Lewis L, Khan AA, Mdladla MN, Mitchell CM, Potloane D. Bacterial Vaginosis [BV] knowledge, attitudes and behavioural changes after BV diagnosis among women enrolled in a clinical trial in Boston, USA and Vulindlela, South Africa: a qualitative study. BMC Womens Health. 2025 Dec 12;26(1):32. doi: 10.1186/s12905-025-04210-3.
• Chetty C, Mafunda N, Happel AU, Khan A, Cooley Demidkina B, Yende-Zuma N, Saidi Y, Mahabeer Polliah A, Lewis L, Osman F, Radebe P, Passmore JS, Kwon D, Ravel J, Ngcapu S, Liebenberg L, Symul L, Holmes S, Mitchell CM, Potloane D. Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial). Contemp Clin Trials Commun. 2025 Sep 16;48:101554. doi: 10.1016/j.conctc.2025.101554. eCollection 2025 Dec.

Drugs

Indications