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

Kimberly-Clark

Status and phase

Completed

Early Phase 1

Conditions

Vaginosis, Bacterial

Treatments

Other: Lactobacillus capsules

Drug: Placebo gelatin pill

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02139839

500-10-0002

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.