Evidence map›Paper›PMID 39836666›Full record

Trial reportPloS one2025

Feasibility, safety and tolerability of estrogen and/or probiotics for improving vaginal health in Canadian African, Caribbean, and Black women: A pilot phase 1 clinical trial.

Biban Gill, Jocelyn M Wessels, Christina L Hayes, Jenna Ratcliffe, Junic Wokuri, Elizabeth Ball, Gregor Reid, Rupert Kaul, Jesleen Rana, Muna Alkhaifi and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03837015 (Improving Vaginal Health to Decrease Biological Risk of HIV-1 Infection in Canadian African, Caribbean and Black), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT03837015 phase1completednot on this map

Improving Vaginal Health to Decrease Biological Risk of HIV-1 Infection in Canadian African, Caribbean and Black (ACB) Women: Estrogen and Probiotic Treatment for Vaginal Health

TypeinterventionalSponsorMcMaster UniversityRan2019 to 2021Enrolled50ConditionsHIV-1-infection, Bacterial VaginosesArmsEstring Vaginal Ring, RepHresh Pro-B
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Role of Vaginal Microbiota and OralBioengineering (Basel, Switzerland) · 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

13 authors.

Biban GillMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.
Jocelyn M WesselsMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.
Christina L HayesMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.
Jenna RatcliffeMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.ORCID 0000-0003-1570-2323
Junic WokuriWomen's Health in Women's Hands Community Health Centre, Toronto, ON, Canada.
Elizabeth BallMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.
Gregor ReidDepartments of Microbiology & Immunology and Surgery, Western University, and Canadian Research and Development Centre for Human Microbiome and Probiotics, The Lawson Health Research Institute, London, ON, Canada.
Rupert KaulDepartments of Immunology and Medicine, University of Toronto, Toronto, ON, Canada.
Jesleen RanaWomen's Health in Women's Hands Community Health Centre, Toronto, ON, Canada.
Muna AlkhaifiWomen's Health in Women's Hands Community Health Centre, Toronto, ON, Canada.
Wangari TharaoWomen's Health in Women's Hands Community Health Centre, Toronto, ON, Canada.
Fiona SmaillDepartment of Pathology and Molecular Medicine and Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Charu KaushicMcMaster Immunology Research Centre and Department of Medicine, McMaster University, Hamilton, ON, Canada.ORCID 0000-0002-7088-2569

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA dysbiotic vaginal microbiome (VMB) is associated with clinical conditions such as bacterial vaginosis (BV) and an increased risk of human immunodeficiency virus (HIV-1) infection. Considering the high prevalence of BV among African, Caribbean and Black (ACB) women, we conducted a prospective, randomized, open-label phase 1 clinical trial to determine the feasibility, safety and tolerability of administering low-dose estrogen, probiotics or both in combination to improve vaginal health and decrease HIV-1 susceptibility.

methodsACB women aged 18-49 from the Greater Toronto Area (GTA) were randomized to one of four study arms: intravaginal estradiol (Estring©; 7.5mg/day); a vaginal probiotic (RepHresh™ Pro-B™) administered twice daily; a combination of Estring© and vaginal RepHresh™ Pro-B™ (twice daily); or the Estring© and oral RepHresh™ Pro-B™ (twice daily), for a duration of 30 days. Feasibility was evaluated through enrolment, retention, and adherence rates, while safety and tolerability were determined by a pre- and post-treatment blood panel and reported adverse events (AEs).

resultsOverall, 63 ACB women were screened, 50 were enrolled and received the intervention while 41 completed the study, resulting in 80% enrollment and 82% retention rates. Overall adherence to the study protocol was high at 93%, with an adherence of 92% for RepHresh™ Pro-B™ and 97% for Estring©. A total of 88 AEs were reported by 29 participants which were mild (66/88; 75%) and largely resolved (82/88;93%) by the end of the study, with no serious AEs (SAEs) noted. In addition, a panel of safety blood markers measured pre- and post-intervention confirmed no clinically significant changes in blood chemistry or blood cell count.

conclusionOverall, the administration of intravaginal estrogen and/or probiotics in pre-menopausal ACB women is feasible, safe, and well tolerated.

trial registrationThe trial was registered with Clinicaltrials.gov (NCT03837015) and CIHR HIV Clinical Trials (CTN308).

Indexed as

EstrogensProbioticsVaginaVaginosis, BacterialAdministration, IntravaginalAdolescentAdultBlack PeopleCanadaCaribbean PeopleFeasibility StudiesFemaleHIV InfectionsHumansMiddle AgedPilot ProjectsEstrogens

Identifiers

PMID39836666
PMCPMC11750099

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.