Observational Study With Mode of Action-Analysis of Cysto... | NCT03019874

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

NCT03019874

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Feb 16, 2021Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Urinary Tract Infections

Interventions

Cranberry Extract

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2018Actual

Completion Date

Feb 2019Actual

First Submitted Date

Jan 2, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2021

Last Update Posted Date

Feb 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Michalsen, Prof. Dr. Andreas Michalsen, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic recurrent Urinary Tract Infections

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Michalsen, Prof. Dr.	Charité University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus		Berlin		14109	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided