NCT02139839

Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14

A Single-Center Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14 on Subjects With Intermediate Nugent Scores

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kimberly-Clark Corporation · Industry
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis of microbial ecology, human microarrays and multiplex immunological assessments are included to characterize potential effects.

Conditions

• Vaginosis, Bacterial

Interventions

Type	Name	Description
OTHER	Lactobacillus capsules	L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen
DRUG	Placebo gelatin pill	Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2014-05-15
• Last updated: 2014-05-15

Locations

1 site across 1 country: Canada