A clinical study to evaluate the usefulness of oral cranberry extract as food supplement in patients with recurrent urinary tract infections

Not Applicable

Completed

• Conditions: Health Condition 1: null- Patients with recurrent and or sub-clinical urinary tract infectionHealth Condition 2: N390- Urinary tract infection, site notspecified

• Registration Number: CTRI/2014/08/004864
• Lead Sponsor: niversity College of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

1. Patients with subclinical (asymptomatic bacteriuria)and or recurrent UTI (three episodes of UTI in the last 12 months or two episodes in the last 6 months).

2.Patients with UTI not responding to antimicrobial therapy due to any cause including multidrug resistance.

3. Patients prone to recurrent UTIs [like geriatric women, geriatric men with symptomatic BPH, patients on clean intermittent catheterization (CIC), chronically catheterized patients (indwelling catheter, suprapubic catheter) patients with spinal cord injury/ stroke / paraplegia/ abnormalities of urinary tract].

4.Patients with subclinical (asymptomatic)/recurrent UTI who are off any antibiotics for the past two weeks.

The working definition of recurrent UTI used by us for this study was : Patients with recurrent UTI ( > 2 episodes) who had culture positive/sensitive UTI and had taken multiple courses of antimicrobials in the past one year or so and desiring alternative therapy were given the option of entering in to this randomized controlled clinical trial (Cranberry extract or lactobacillus capsules).

Exclusion Criteria

1. Patients with the first episode of symptomatic active UTI (defined as >100000 bacteria/HPF in midstream urine culture).

2.Pregnant and or lactating patients.

3.Patients in the pediatric age group.

4.Patients with known history of hypersensitivity to PAC-A /Cranberry extract.

5. Patients with known history of hyperoxaluria/known renal oxalate stone formers.

6. Patients not consenting for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of standardized oral preparation of Cranberry extract (containing 120 mgs of Proantrocyanidin-A) as a nutritional supplement versus placebo (Lactobacillus capsule)on the various in-vitro bacterial properties of uropathogenic bacteria (like E. coli) in the urine of patients with subclinical (asymptomatic) UTI and in patients prone to recurrent UTI. <br/ ><br>Timepoint: Change in the recorded parameters at 3, 6 and 12 weeks after therapy with interventional/comparator agent

Secondary Outcome Measures

Name	Time	Method
To study the efficacy and tolerability of the standardized oral preparation of Cranberry extract (containing 120 mgs of Proantrocyanidin-A)as a nutritional supplement versus a placebo Lactobacillus capsule)in patients with subclinical (asymptomatic)/recurrent UTI.Timepoint: Change in the recorded parameters at 3, 6 and 12 weeks after therapy with interventional/comparator agent