Can Consumption of an Aronia-mixture Prevent Urinary Tract Infections in Female Patients?

NCT06618768 | Completed DMC

• 1 other identifier: 422796 (REK)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to determine the feasibility of conducting a randomised clinical trial to measure the effectiveness of an aronia mixture in reducing recurrence of urinary tract infections (UTIs) and antibiotic use by women with a history of frequent UTIs. In addition, the study aim to collect data in order to establish power calculations required for a full-scale study.

Conditions

Urinary Tract Infection (Diagnosis)

Keywords

clinical trial; primary care; urinary tract infection

Outcome Measures

Primary Outcomes (4)

• Study feasibility: recruitment of participants

  Experiences related to the process of recruiting study participants

  From enrollment to end of treatment at 6 months

• Study feasibility: drop-outs

  Register the number of dropouts during the intervention period

  From enrollment to end of treatment at 6 months

• Study feasibility: program adherence

  Examine adherence to the program by study participants and staff

  From enrollment to end of treatment at 6 months

• Study feasibility: duration of the intervention period

  Acceptance of treatment duration among participants and recruiters

  From enrollment to end of treatment at 6 months

Secondary Outcomes (1)

• Number of Urinary Tract Infections (UTIs) during the intervention period

  From enrollment to end of treatment at 6 months

Study Arms (1)

Consumption of an aronia-mixture

EXPERIMENTAL

Participants will daily consume 1 dL aronia-mixture for 6 months. The mixture may be consumed in smaller portions throughout the day, but according to results from a non-clinical pilot-study (https://pubmed.ncbi.nlm.nih.gov/25026919/), the mixture should be consumed with a meal in order to avoid nausea. The aronia-mixture has been developed by the research group and produced for free by Ronia AS, Randaberg, Norway. The mixture is produced from aronia-berries (50%) and apples (50%), and 1 dL (one serving) consists of 600 mg proanthocyanidins, 300 mg anthocyanins and 100 mg chlorogenic acids with pH 3.6. Urine samples (25 mL) will be delivered at general practices for chemical analysis of metabolites from the intervention drink at day 0, 60, 120, and 180 (spot urine). In addition, an urine sample will be collected at day 0 for microbiological analysis (urine culture). The intervention will not replace any medical treatment during the project period.

Dietary Supplement: Consumption of an aronia-mixture to prevent Urinary Tract Infections in female patients

Interventions

Consumption of an aronia-mixture to prevent Urinary Tract Infections in female patients DIETARY_SUPPLEMENT

The present pilot study will assess the feasibility of methods and procedures to be used in a larger study and contribute to establish power calculations required to conduct a randomised clinical trial which will examine whether consumption of 1 dL aronia-mixture/day for six months will reduce prevalence of symptomativ UTi episodes among adult women with a recent history of uncomplicated, recurrent UTIs.

Consumption of an aronia-mixture

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The target group of the present study is females, as urinary tract infections are about 50 times more common in women than men. Thus, inclusion criteria is focusing on their biological sex and not their gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years old
• Recurrent urinary tract infections (rUTI) (minimum of 2 episodes in the last 6 months, or minimum of 3 episodes in the last 12 months).
• Participants should be cooperative, capable of maintaining a patient diary, and providing urine samples according to a specified schedule.

You may not qualify if:

• Use of Hiprex in the last 6 months.
• Regular use of aronia in the last 6 months.
• Allergy to heat-treated aronia or apple.
• Uncontrolled diabetes mellitus.
• Use of blood-thinning medication (e.g. Warfarin).

Sponsors & Collaborators

• University of Agder: lead
• Ullevaal University Hospital: collaborator
• Sorlandet Hospital HF: collaborator

Study Sites (1)

University of Agder

Kristiansand, 4604, Norway

Location

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)