Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease.
Humans
Female
Vaginosis, Bacterial
/ drug therapy
Metronidazole
/ administration & dosage
Anti-Bacterial Agents
/ administration & dosage
Adult
Lactobacillus crispatus
/ physiology
Probiotics
/ administration & dosage
Treatment Outcome
Recurrence
Secondary Prevention
Administration, Intravaginal
Young Adult
Vagina
/ microbiology
Double-Blind Method
Journal
Sexually transmitted diseases
ISSN: 1537-4521
Titre abrégé: Sex Transm Dis
Pays: United States
ID NLM: 7705941
Informations de publication
Date de publication:
01 Jun 2024
01 Jun 2024
Historique:
medline:
12
5
2024
pubmed:
12
5
2024
entrez:
11
5
2024
Statut:
ppublish
Résumé
Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure. LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.
Identifiants
pubmed: 38733973
doi: 10.1097/OLQ.0000000000001962
pii: 00007435-202406000-00010
doi:
Substances chimiques
Metronidazole
140QMO216E
Anti-Bacterial Agents
0
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase II
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
437-440Informations de copyright
Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of Interest and Sources of Funding: C.R.C. serves on the scientific advisory boards of Osel Inc. and Evvy Inc. and has received stock options from both companies.
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