Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women (UTIReuteri)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03019172
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

Brief Summary:
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Combination Product: Lactobacillus reuteri Dietary Supplement: Sachet with cranberry + placebo Not Applicable

Detailed Description:
Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency of clinical or bacteriological cure. Secondary outcomes will be a) time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo; b) frequency of clinical/laboratory and bacteriologic relapse in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo, at day 30 after treatment start and c) frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 + cranberry extract. The control group will recibe Cranberry extract. The products will be taken twice per day, morning and evening.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial, double blind allocation concealment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)
Actual Study Start Date : March 5, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactobacillus reuteri
Women in experimental branch will receive two sachets. Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
Combination Product: Lactobacillus reuteri
Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5*10^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc

Placebo Comparator: Sachet with cranberry + placebo
Women in control branch will receive two sachets. Sachet one contains only Maltodextrin and sachet two contains instant cranberry drinkcomposed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica Both sachets should be emptied in a glass and mixed with 200 ml of cold water
Dietary Supplement: Sachet with cranberry + placebo
Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.




Primary Outcome Measures :
  1. clinical and bacteriological cure [ Time Frame: 30 days ]
    Frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo


Secondary Outcome Measures :
  1. clinical or bacteriological relapse [ Time Frame: 30 days ]
    Time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo

  2. Adverse events [ Time Frame: 14 days ]
    • Frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non pregnant pre menopausal women
  • Minimum age 18 years
  • Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes esterase

    • and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+ clinical symptoms) and an evaluation of the presence of typical related symptoms. In particular, frequency (frequent voiding of urine), urgency (the urge to void immediately), dysuria (painful voiding), and/or suprapubic pain.
  • Verbal and Written Informed Consent for participation in the study

Exclusion Criteria:

  • Acute cystitis symptoms for >1week before the first visit
  • Diabetes mellitus,
  • Congenital urinary tract abnormality
  • Lactating women
  • Female who intend to become pregnant during the study or within 3 months after the completion of the study
  • Vaginal discharge + fever (>37.5oC)
  • Diagnostic of sexually transmitted diseases
  • Use of an indwelling catheter or an intermittent self-catheterisation program
  • Presence of neurogenic bladder, or
  • Use of any antibiotic 2 weeks before Day 1 in the study.

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): NCT03019172


Locations
Layout table for location information
Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Tlalpan, Mexico, 14080
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud

Publications:
Layout table for additonal information
Responsible Party: Pedro Gutierrez Castrellon, MD, MSc, DSc, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03019172     History of Changes
Other Study ID Numbers: UTIReuteri2016
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action