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Rwanda Vaginal Microbiota Restoration Study

NCT02459665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-07-16

Study results available
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Summary

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

Conditions

  • Bacterial Vaginosis

Interventions

BIOLOGICAL

Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

DRUG

Prophylactic use of metronidazole pills (500 mg)

Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV

BIOLOGICAL

Vaginal Lcr35-containing probiotic for prevention of BV recurrence

Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV

Sponsors & Collaborators

  • Rinda Ubuzima, Rwanda

    collaborator UNKNOWN

  • Janneke van de Wijgert

    lead OTHER

Principal Investigators

  • Janneke H van de Wijgert, PhD · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2016-02-23
Completion
2018-08-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459665 on ClinicalTrials.gov