NCT03019874

Brief Summary

The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. In a secondary analysis the possible influence of the microbiota changes on the recurrence frequency in the follow-up should be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

January 2, 2017

Last Update Submit

February 15, 2021

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Number of urinary tract infections

    In the 6-month prospective observation period compared to a 6-month retrospective period

Secondary Outcomes (1)

  • Quality of life (SF-36)

    Baseline, 4 weeks, 8 weeks, 6 months

Other Outcomes (1)

  • Stool analysis: Intestinal microbiome by sequencing 16S rRNA

    Baseline, 4 weeks, 8 weeks, 6 months

Interventions

Cranberry ExtractDIETARY_SUPPLEMENT

3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic recurrent Urinary Tract Infections

You may qualify if:

  • chronic recurrent urinary tract infections (≥3 infections per year or 2 infections in the last 6 months)

You may not qualify if:

  • renal insufficiency (GFR \<60),
  • anatomical or known structural causes of urinary tract infections
  • regular consumption of probiotics or probiotic yogurts (at least 5x / week)
  • intake of antibiotics in the last 4 weeks
  • intake of Marcumar
  • simultaneous participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charité University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andreas Michalsen

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 13, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

DE(1)