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

NCT ID: NCT03019172

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-05

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, double blind allocation concealment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Lactobacillus reuteri

Intervention Type COMBINATION_PRODUCT

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

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

Group Type PLACEBO_COMPARATOR

Sachet with cranberry + placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Innovacion y Desarrollo de Estrategias en Salud

OTHER

Sponsor Role lead

Responsible Party

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Pedro Gutierrez Castrellon

MD, MSc, DSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 27084704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26695595 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26298938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25291140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23433130 (View on PubMed)

Other Identifiers

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UTIReuteri2016

Identifier Type: -

Identifier Source: org_study_id