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

Urinary Tract Infections Clinical Trial

— UTIReuteri  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019172
• Other study ID #: UTIReuteri2016
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: November 27, 2017
• Start date: March 5, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: November 2017
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

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

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.

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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

Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;(12):CD008772. doi: 10.1002/14651858.CD008772.pub2. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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