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Completed

NCT Number: NCT03019874

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry Extract

Dietary 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)

Primary outcomes

  1. Number of urinary tract infections

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

Secondary outcomes

  1. Quality of life (SF-36)

    Time frame: Baseline, 4 weeks, 8 weeks, 6 months

Other outcomes

  1. Stool analysis: Intestinal microbiome by sequencing 16S rRNA

    Time frame: Baseline, 4 weeks, 8 weeks, 6 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 13, 2017
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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