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

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Combination Product: Lactobacillus reuteri; Dietary Supplement: Sachet with cranberry + placebo

• Registration Number: NCT03019172
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-03-05
• Primary Completion: 2017-07-30
• Study Completion: 2017-09-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri	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.
Sachet with cranberry + placebo	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

Primary Outcome Measures

Name	Time	Method
clinical and bacteriological cure	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

Name	Time	Method
clinical or bacteriological relapse	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
Adverse events	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

Trial Locations

Locations (1)

Hospital General Dr. Manuel Gea Gonzalez; 🇲🇽 Mexico city, Tlalpan, Mexico