Evidence map›Paper›PMID 41050878›Full record

ArticleContemporary clinical trials communications2025

Randomized trial of multi-strain

Callin Chetty, Nomfuneko Mafunda, Anna-Ursula Happel, Anam Khan, Briah Cooley Demidkina, Nonhlanhla Yende-Zuma, Yusra Saidi, Asthu Mahabeer Polliah, Lara Lewis, Farzana Osman and 10 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06135974 (Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06135974 early_phase1completednot on this map

Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

TypeinterventionalSponsorMassachusetts General HospitalRan2024 to 2025Enrolled24ConditionsBacterial VaginosisArmsLC106, LC115, Placebo, Metronidazole Oral
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Fabrication of bioprints self-coated with thermally sensitive lactobacilli for CAUTI applications.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2026
    Article
  4. Review
  5. Review
  6. Microbiota effects and predictors ofmedRxiv : the preprint server for health sciences · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Callin ChettyCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Nomfuneko MafundaVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, United States of America.
Anna-Ursula HappelInstitute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa.
Anam KhanVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, United States of America.
Briah Cooley DemidkinaVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, United States of America.
Nonhlanhla Yende-ZumaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Yusra SaidiVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, United States of America.
Asthu Mahabeer PolliahCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Lara LewisCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Farzana OsmanCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Precious RadebeCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Jo-Ann S PassmoreDivision of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Doug KwonRagon Institute of MGH, Harvard and MIT, Cambridge, United States of America.
Jacques RavelInstitute for Genome Sciences, University of Maryland School of Medicine, Baltimore, MD, United States of America.
Sinaye NgcapuCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Lenine LiebenbergCentre for Epidemic Response and Innovation (CERI), Stellenbosch University, Cape Town, South Africa.
Laura SymulDepartment of Statistics, Universite Catholique de Louvain, Louvain, Belgium.
Susan HolmesDepartment of Statistics, Stanford University, Palo Alto, United States of America.
Caroline M MitchellVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, United States of America.
Disebo PotloaneCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 Conclusions: This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal Trial registration: South African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 11, 2023). Protocol version: 2.0 dated October 03, 2023.

Indexed as

Bacterial vaginosisLactobacillus crispatusLive biotherapeutic productVaginal healthVaginal microbiomeWomen's health

Identifiers

PMID41050878
PMCPMC12495413

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.