Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women (RVMM)

May 29, 2014 updated by: Dr. Gregor Reid, Western University, Canada

Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
    • East Province
      • Nyamata, East Province, Rwanda
        • Nyamata District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women between the ages of 18 and 55.

Exclusion Criteria:

  • *Current infection of gonorrhoea, *Chlamydia, genital warts, *active genital herpes lesions, *active syphilis; *urinary tract infection including pyelonephritis (an ascending urinary tract infection); *receiving drug therapy that may affect the vaginal flora; *had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; *have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; *have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; *are menstruating at time of clinical visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Sugar pill
Biological: Placebo
Other Names:
  • Sugar pill
Experimental: Probiotic
Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules
Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maintenance of healthy vaginal microbiota
Time Frame: 1 month
The change in relative abundance of healthy lactobacilli and species associated with bacterial vaginosis after one month probiotic intervention will be assessed using 16S rRNA gene sequencing.
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of environmental toxins in blood by lactobacilli
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: Gregor Dr Reid, PhD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102886

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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