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

NCT02150655 | Completed Early Phase 1

• 1 other identifier: 102886
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvovaginal Candidiasis; Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• maintenance of healthy vaginal microbiota

  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 Outcomes (1)

• Reduction of environmental toxins in blood by lactobacilli

  1 month

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 oral capsules

Biological: Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules

Placebo

PLACEBO COMPARATOR

Sugar pill

Biological: Placebo

Interventions

Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules BIOLOGICAL

Probiotic

Placebo BIOLOGICAL

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between the ages of 18 and 55.

You may not qualify if:

• \*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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Nyamata District Hospital

Nyamata, East Province, Rwanda

Location

Related Publications (1)

• McMillan A, Rulisa S, Gloor GB, Macklaim JM, Sumarah M, Reid G. Pilot assessment of probiotics for pregnant women in Rwanda. PLoS One. 2018 Jun 18;13(6):e0195081. doi: 10.1371/journal.pone.0195081. eCollection 2018.

  PMID: 29912913 DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Vaginosis, Bacterial

Interventions

Sugars

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Bacterial Infections

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Gregor Dr Reid, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Canadian R&D Centre for Probiotics

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: May 30, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

RW (1)