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

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lactobacillus reuteri
Sachet with cranberry + placebo
Sponsored by
Innovacion y Desarrollo de Estrategias en Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General Dr. Manuel Gea Gonzalez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus reuteri

Sachet with cranberry + placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

clinical and bacteriological cure
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

clinical or bacteriological relapse
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
Adverse events
• 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

Full Information

First Posted
January 10, 2017
Last Updated
November 27, 2017
Sponsor
Innovacion y Desarrollo de Estrategias en Salud
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1. Study Identification

Unique Protocol Identification Number
NCT03019172
Brief Title
Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women
Acronym
UTIReuteri
Official Title
Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 5, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Innovacion y Desarrollo de Estrategias en Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, double blind allocation concealment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri
Arm Type
Experimental
Arm Description
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.
Arm Title
Sachet with cranberry + placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Lactobacillus reuteri
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Sachet with cranberry + placebo
Intervention Description
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 Measure Information:
Title
clinical and bacteriological cure
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
clinical or bacteriological relapse
Description
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
Time Frame
30 days
Title
Adverse events
Description
• 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
Time Frame
14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital General Dr. Manuel Gea Gonzalez
City
Mexico city
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27084704
Citation
Lee BB, Toh SL, Ryan S, Simpson JM, Clezy K, Bossa L, Rice SA, Marial O, Weber G, Kaur J, Boswell-Ruys C, Goodall S, Middleton J, Tudehope M, Kotsiou G. Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial. BMC Urol. 2016 Apr 16;16:18. doi: 10.1186/s12894-016-0136-8.
Results Reference
background
PubMed Identifier
26695595
Citation
Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
Results Reference
background
PubMed Identifier
26298938
Citation
Chisholm AH. Probiotics in Preventing Recurrent Urinary Tract Infections in Women: A Literature Review. Urol Nurs. 2015 Jan-Feb;35(1):18-21, 29.
Results Reference
background
PubMed Identifier
25291140
Citation
Vicariotto F. Effectiveness of an association of a cranberry dry extract, D-mannose, and the two microorganisms Lactobacillus plantarum LP01 and Lactobacillus paracasei LPC09 in women affected by cystitis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S96-101. doi: 10.1097/MCG.0000000000000224.
Results Reference
background
PubMed Identifier
23433130
Citation
Grin PM, Kowalewska PM, Alhazzan W, Fox-Robichaud AE. Lactobacillus for preventing recurrent urinary tract infections in women: meta-analysis. Can J Urol. 2013 Feb;20(1):6607-14.
Results Reference
background

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

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