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

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ClinicalTrials.gov Identifier: NCT02139839
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Collaborators:
Lawson Health Research Institute
Western University, Canada
Integrated Research Inc.
Information provided by (Responsible Party):
Kimberly-Clark Corporation

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.

Condition or disease Intervention/treatment Phase
Vaginosis, Bacterial Other: Lactobacillus capsules Drug: Placebo gelatin pill Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Gelatin pill first 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.

Experimental: Lactobacillus capsules first 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.




Primary Outcome Measures :
  1. Change from baseline Nugent Score (arbitrary units) after treatment versus Change from baseline Nugent Score after placebo [ Time Frame: Baseline Days 15 & 36, post treatment/control Days 19 & 40 ]
    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.


Secondary Outcome Measures :
  1. Percent Lactobacilli abundance [ Time Frame: 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 lactobacilli abundance before and after probiotic treatment and before and after placebo treatment. Lactobacilli abundance will be calculated as percentage of number of lactobacilli taxon divided by the total number of taxons.

  2. Change in presence of metabolites [ Time Frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47) ]
    Gas chromatography-mass spectrometry will be used to determine changes in metabolites (such as lactate, glutamic acid, and others) before and after probiotic and placebo treatments.

  3. Change in cytokine/chemokine levels [ Time Frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47) ]
    Multiplex ELISA based assay will be used to evaluate the modulation of cytokine and chemokine levels known regulate inflammation and host defense response before and after probiotic and placebo treatment.

  4. Change in global host gene expression [ Time Frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47) ]
    Microarray analysis using GeneChip Human 2.0 ST array will be used to measure gene expression changes (by mRNA analysis) to determine whether there are differences in gene regulation between probiotic, placebo, and no treatment conditions.

  5. Change in self-reported vaginal symptoms [ Time Frame: Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47) ]
    Symptom analysis to evaluate whether probiotic treatment is associated with symptom relief.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139839


Locations
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Canada, Ontario
Dorli Herman
London, Ontario, Canada, N6J 0A8
Sponsors and Collaborators
Kimberly-Clark Corporation
Lawson Health Research Institute
Western University, Canada
Integrated Research Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kimberly-Clark Corporation
ClinicalTrials.gov Identifier: NCT02139839    
Other Study ID Numbers: 500-10-0002
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Vaginitis