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

Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Combination product: Lactobacillus reuteri; Dietary supplement: Sachet with cranberry + 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Tlalpan
    • Mexico city, Tlalpan, Mexico, 14080
      • Hospital General Dr. Manuel Gea Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days
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	14 days

Collaborators and Investigators

• Sponsor: Innovacion y Desarrollo de Estrategias en Salud

Publications and helpful links

General Publications

• 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.
• 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.
• Chisholm AH. Probiotics in Preventing Recurrent Urinary Tract Infections in Women: A Literature Review. Urol Nurs. 2015 Jan-Feb;35(1):18-21, 29.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: UTIReuteri2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No