NCT03597152

Brief Summary

The study will test the ability of specially formulated nutritional supplement capsules to extend the time between recurrent urinary tract infections in women. This objective will be completed by enrolling women who have suffered from 3-4 uncomplicated UTIs in the past 12 months into a double blind placebo controlled cross-over trial. Cross-over and study completion are triggered by the next two UTI recurrences. The goal of the study is for the supplement to extend the time to the next UTI for study participants as compared to placebo.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Status
unknown

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

July 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

July 13, 2018

Last Update Submit

January 8, 2020

Conditions

Recurrent Urinary Tract Infection

Keywords

uncomplicated recurrent urinary tract infection

Outcome Measures

Primary Outcomes (1)

  • UTI Recurrence

    Time to recurrence of next UTI

    Variable for each participant over course of up to one year

Study Arms (2)

Treatment

EXPERIMENTAL

WelTract

Dietary Supplement: WelTract

Control

PLACEBO COMPARATOR

Inert Placebo

Dietary Supplement: Placebo

Interventions

WelTractDIETARY_SUPPLEMENT

Supplement commercially available from the sponsor containing powdered extracts from Hibiscus flowers and cranberry fruit, lactoferrin, D-mannose, and vitamins C and D

Treatment
PlaceboDIETARY_SUPPLEMENT

Inert placebo custom manufactured for the sponsor

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNot based on self-representation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting with symptoms of UTI
  • Presentation of 3rd or 4th simple cystitis of lower tract in the past 12 months
  • Active infection at enrollment, confirmed and documented in medical record
  • Cognitive capacity to consent and ability to undergo the consent process in English

You may not qualify if:

  • Known allergy or intolerance to supplement ingredients
  • Pregnant or planning to become pregnant or lactating
  • Unwilling to commit to birth control use
  • Use of related nutritional supplements
  • Unwilling to halt berry extracts, polyphenols, antioxidants, d-mannose, vitamins
  • Taken WelTract in past six months
  • Unwilling to avoid probiotics, yogurt, apple or cranberry juice, hibiscus tea
  • Certain comorbid or physical conditions
  • History of febrile UTI
  • Bladder catheter or urethral stents
  • Use of topical hormones in urogenital areas
  • Diabetes (i.e. taking diabetic medications) or glycosuria
  • Intestinal diseases with malabsorption (e.g. Crohn's and celiac diseases)
  • Severe renal impairment or kidney stones
  • Neural problems (spinal cord injury or Multiple Sclerosis)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

    PMID: 37947276DERIVED

  • Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

    PMID: 37068952DERIVED

  • Cooper TE, Teng C, Howell M, Teixeira-Pinto A, Jaure A, Wong G. D-mannose for preventing and treating urinary tract infections. Cochrane Database Syst Rev. 2022 Aug 30;8(8):CD013608. doi: 10.1002/14651858.CD013608.pub2.

    PMID: 36041061DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Richard D'Anna, MD

    Arkansas Urology, Staff Physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie O'Brien

CONTACT

501-219-8900katie@arkansasurology.com

Richard Dennis, PhD

CONTACT

501-960-8024protocols@att.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 24, 2018

Study Start

August 1, 2020

Primary Completion

January 14, 2022

Study Completion

December 31, 2022

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share