Clinical trial NCT03019172: Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women
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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Innovacion y Desarrollo de Estrategias en Salud
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, double blind allocation concealment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical and bacteriological cure
timeFrame: 30 days
Secondary outcomes:
measure: clinical or bacteriological relapse
timeFrame: 30 days
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General Dr. Manuel Gea Gonzalez
state: Tlalpan
Study officials:
References:
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.
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.
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.
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.
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.