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

Innovation and Development of Health Strategies

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Dietary Supplement: Sachet with cranberry + placebo; Combination Product: Lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT03019172

UTIReuteri2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri

Experimental group

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.

Treatment:

Combination Product: Lactobacillus reuteri

Sachet with cranberry + placebo

Placebo Comparator group

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

Treatment:

Dietary Supplement: Sachet with cranberry + placebo