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

NCT ID: NCT02139839

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gelatin pill first

Group Type: PLACEBO_COMPARATOR

Lactobacillus capsules

Intervention Type: OTHER

L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen

Placebo gelatin pill

Intervention Type: DRUG

Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.

Lactobacillus capsules first

Group Type: EXPERIMENTAL

Lactobacillus capsules

Intervention Type: OTHER

L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen

Placebo gelatin pill

Intervention Type: DRUG

Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.

Interventions

Lactobacillus capsules

L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing and able to read, understand, and sign the Informed Consent Form (ICF);
• Post-menopausal females between the ages of 40 and 80 years old (subjects who have not had a menstrual period for the last 12 months);
• Currently in a mutually monogamous sexual relationship or not sexually active;
• Agree to be sexually abstinent 72 hours prior to each study visit. Also, agree to refrain from intercourse for 48 hours after treatment administration;
• Agree to abstain from the use of any other intravaginal product (e.g. gels, foams, lubricants, douches, etc.) throughout the study period, from the time of screening until Day 47;
• Willing and capable of following all study instructions; and
• Good general health.

Exclusion Criteria

• Use of vaginal lubricants, or any products applied vaginally within three months prior to Visit 1and throughout the duration of study participation;
• A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy;
• A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant);
• Antibiotics and/or antifungal medication use within the last four (4) weeks;
• Oral probiotic supplement use within 3 months prior to Visit 1 and throughout the duration of the study;
• Significant changes in diet during the course of the study based on self-report;
• Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment;
• Currently undergoing local or systemic estrogen therapy who are not willing to alter therapy during the course of the study;
• A Nugent Score of 0 - 3 or greater than 6;
• History of drug or alcohol abuse;
• Currently diagnosed with or being treated for a genital infection or urinary tract infection;
• Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator);
• At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives;
• Participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently; and
• Known intolerance or allergy to L. rhamnosus GR-1® or L. reuteri RC-14® or to any product excipients.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

Integrated Research Inc.

INDUSTRY

Sponsor Role: collaborator

Kimberly-Clark Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dorli Herman

London, Ontario, Canada

Countries

Canada

References

Bisanz JE, Seney S, McMillan A, Vongsa R, Koenig D, Wong L, Dvoracek B, Gloor GB, Sumarah M, Ford B, Herman D, Burton JP, Reid G. A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women. PLoS One. 2014 Aug 15;9(8):e104511. doi: 10.1371/journal.pone.0104511. eCollection 2014.

Reference Type: DERIVED

PMID: 25127240 (View on PubMed)

Other Identifiers

500-10-0002

Identifier Type: -

Identifier Source: org_study_id