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

NCT02139839 | Completed Early Phase 1

• 1 other identifier: 500-10-0002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline Nugent Score (arbitrary units) after treatment versus Change from baseline Nugent Score after placebo

  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 for one week as measured by a decrease in the Nugent Scores from an intermediate score (4 - 6) at baseline to a normal score (0 - 3) following treatment compared to a placebo.

  Baseline Days 15 & 36, post treatment/control Days 19 & 40

Secondary Outcomes (5)

• Percent Lactobacilli abundance

  Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)

• Change in presence of metabolites

  Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)

• Change in cytokine/chemokine levels

  Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)

• Change in global host gene expression

  Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)

• Change in self-reported vaginal symptoms

  Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47)

Study Arms (2)

Gelatin pill first

PLACEBO COMPARATOR

Other: Lactobacillus capsules; Drug: Placebo gelatin pill

Lactobacillus capsules first

EXPERIMENTAL

Other: Lactobacillus capsules; Drug: Placebo gelatin pill

Interventions

Lactobacillus capsules OTHER

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

Gelatin pill first; Lactobacillus capsules first

Placebo gelatin pill DRUG

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

Gelatin pill first; Lactobacillus capsules first

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kimberly-Clark Corporation: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• Western University, Canada: collaborator
• Integrated Research Inc.: collaborator

Study Sites (1)

Dorli Herman

London, Ontario, N6J 0A8, Canada

Location

Related Publications (1)

• 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.

  PMID: 25127240 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 15, 2014
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

CA (1)