NCT03019172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

January 10, 2017

Last Update Submit

November 27, 2017

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • clinical or bacteriological relapse

    30 days

  • Adverse events

    14 days

Study Arms (2)

Lactobacillus reuteri

EXPERIMENTAL

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.

Combination Product: Lactobacillus reuteri

Sachet with cranberry + placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Sachet with cranberry + placebo

Interventions

Lactobacillus reuteriCOMBINATION_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

Lactobacillus reuteri
Sachet with cranberry + placeboDIETARY_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.

Sachet with cranberry + placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 27084704BACKGROUND

  • 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.

    PMID: 26695595BACKGROUND

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

    PMID: 26298938BACKGROUND

  • 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.

    PMID: 25291140BACKGROUND

  • 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.

    PMID: 23433130BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial, double blind allocation concealment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, DSc

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

March 5, 2017

Primary Completion

July 30, 2017

Study Completion

September 30, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)