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)

Chetty, Callin; Mafunda, Nomfuneko; Happel, Anna-Ursula; Khan, Anam; Cooley Demidkina, Briah; Yende-Zuma, Nonhlanhla; Saidi, Yusra; Mahabeer Polliah, Asthu; Lewis, Lara; Osman, Farzana; Radebe, Precious; Passmore, Jo-Ann S.; Kwon, Doug; Ravel, Jacques; Ngcapu, Sinaye; Liebenberg, Lenine; Symul, Laura; Holmes, Susan; Mitchell, Caroline; Potloane, Disebo

doi:10.1016/j.conctc.2025.101554

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)

Chetty, Callin

;

Mafunda, Nomfuneko

;

Happel, Anna-Ursula

;

Khan, Anam

;

Potloane, Disebo

;et.al.

(2025) Contemporary Clinical Trials Communications — Vol. 48, p. 101554 (2025)

Files

ISBA_RP_2026-28.pdf

Open Access
Adobe PDF
948.81 KB

Download

Details

Authors

Chetty, Callin
Author
Mafunda, Nomfuneko
Author
Happel, Anna-Ursula
Author
Khan, Anam
Author
Symul, LauraUCLouvain
Author
Potloane, Disebo
Author

Abstract

Background : Globally, approximately 30 % of women have bacterial vaginosis (BV). Antibiotic treatment is frequently followed by recurrence, likely due to lack of colonization with beneficial lactobacilli. Methods : This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish Lactobacillus colonization. The LBP are vaginal tablets containing 6 L. crispatus strains (LC106) or 15 L. crispatus strains (LC115), at 2 x 109 colony forming units (CFU) per dose. Participants with BV in the United States and South Africa will receive seven days of oral metronidazole twice daily and will be randomized 1:1:1:1:1 to: seven days placebo; seven days LC106; three days LC106/four days placebo; seven days LC106 starting day 3 of the metronidazole course; or seven days LC115. Safety will be assessed by the number and percentage of ≥ Grade 2 related adverse events during or after product use. The primary outcome is LBP colonization defined as relative abundance ≥5 % of any LBP strain or ≥10 % of a combination of LBP strains by metagenomic sequencing any time in the 5 weeks after randomization. A generalized linear model will measure the association between treatment group and colonization, adjusting for site. Conclusions : This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal L. crispatus colonization in two geographically distinct populations.

Affiliations

UCLouvainSSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles

Citations

APA
Chicago
FWB

Chetty, C., Mafunda, N., Happel, A.-U., Khan, A., Cooley Demidkina, B., Yende-Zuma, N., Saidi, Y., Mahabeer Polliah, A., Lewis, L., Osman, F., Radebe, P., Passmore, J.-A. S., Kwon, D., Ravel, J., Ngcapu, S., Liebenberg, L., Symul, L., Holmes, S., Mitchell, C., & Potloane, D. (2025). 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). Contemporary Clinical Trials Communications, 48, 101554. https://doi.org/10.1016/j.conctc.2025.101554 (Original work published 2025)