Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections

February 15, 2021 updated by: Andreas Michalsen, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic recurrent Urinary Tract Infections

Description

Inclusion criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of urinary tract infections
Time Frame: In the 6-month prospective observation period compared to a 6-month retrospective period
In the 6-month prospective observation period compared to a 6-month retrospective period

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (SF-36)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months
Baseline, 4 weeks, 8 weeks, 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Stool analysis: Intestinal microbiome by sequencing 16S rRNA
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months
Baseline, 4 weeks, 8 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Andreas Michalsen, Prof. Dr., Charité University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRANBERRY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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