Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI’s)

Overview

To investigate if administration of probiotics, either orally or vaginally,

- Can reduce the number of episodes of acute bacterial cystitis and/or

- Has tolerable adverse effect profile

- Improves general QoL in these women

- Improves the immune function and other physiological stress markers

- Reduces inflammation in urinary bladder epithelium

Full Title of Study: “Probiotics/Lactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women. A Randomized, Prospective, Double-Blinded, Placebo Controlled, Multi-Center Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2009

Detailed Description

Chronic recurrent bacterial cystitis is a condition that is disabling to a great extent and which influences quality of life and freedom of movement. The episodes can be painful, and lead to extensive use of antibiotics, which in itself promotes development of bacterial strains increasingly resistant to antibiotics, but do not prevent relapses. Almost all cystitis' in women are ascending infections from bacteria in the vagina, following colonization from the rectum. There have, however, been reported indications that there may be bacteria colonies within the urothelium that might give rise to relapses of the infections, rather than pure reinfection from ascending pathogens.

Probiotics are cultures of viable microorganisms, which show a positive effect on the general condition of the host when administered. Among the lactic acid bacteria (LAB), lactobacilli are the most commonly used for probiotics, and they have an excellent safety record. In terms of UTI, weekly or twice weekly intravaginal instillation of Lactobacillus strains GR-1 and B-54 have led to reduced recurrences. This concept has been supported by a 2006 pilot study showing that intravaginal administration of Lactobacillus crispatus GAI 98322 every two days for one year, had the potential to reduce the UTI recurrences. Another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina. The studies have shown that L. rhamnosus GR-1 and L. reuteri (formerly fermentum) RC-14 can reach the vagina after daily oral ingestion, and they can lower the bacterial and yeast pathogen numbers.

The aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause UTI.

Interventions

  • Dietary Supplement: UREX-cap-5
    • Size 3, white/white capsule, each containing 180 mg of a standardized, light beige fine powder consisting of freeze-dried cultures of: Lactobacillus rhamnosus, GR-1® (50%) Lactobacillus reuteri, RC-14® (50%) Ingredients Powder: Cultures, glucose anhydrate, potato starch, microcrystalline cellulose and magnesium stearate. Capsule: Gelatine, titanium dioxide Concentration Minimum of 5.4 billion (5.4 x 109) Colony Forming Units per capsule by end of bulk shelf life. Application For use as a dietary supplement. Packaging 20,000 capsules packaged in heat-sealed foil pouch.
  • Dietary Supplement: UREX-cap-5
    • Size 3, white/white capsule, each containing 180 mg of a standardized, light beige fine powder consisting of freeze-dried cultures of: Lactobacillus rhamnosus, GR-1® (50%) Lactobacillus reuteri, RC-14® (50%) Ingredients Powder: Cultures, glucose anhydrate, potato starch, microcrystalline cellulose and magnesium stearate. Capsule: Gelatine, titanium dioxide Concentration Minimum of 5.4 billion (5.4 x 109) Colony Forming Units per capsule by end of bulk shelf life. Application For use as a dietary supplement. Packaging 20,000 capsules packaged in heat-sealed foil pouch.
  • Dietary Supplement: Placebo Y cap G-3
    • Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months

Arms, Groups and Cohorts

  • Active Comparator: Probiotic vaginal capsules
    • Probiotic vaginal capsule, placebo oral capsule
  • Placebo Comparator: placebo
    • placebo oral capsule, placebo vaginal capsule
  • Active Comparator: Probiotic oral capsules
    • Probiotic oral capsules, placebo vaginal capsules

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in number og episodes og lower UTI
    • Time Frame: 6 months intervention period
  • Improvement of QOL
    • Time Frame: 6 months intervention period

Secondary Measures

  • Improvement of immune function
    • Time Frame: 6 months
  • Effects are non-dependant og nutritional status
    • Time Frame: 6 month2
  • Effects are non-dependant of known factors contributing til UTI’s
    • Time Frame: 6 months
  • Decreases inflammation in the urinary bladder epithelium
    • Time Frame: 6 months
  • Normalizes vaginal microflora
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • women 18-70 years old
  • spontaneous urination
  • > 3 UTI's previous year
  • no ongoing prophylactic antibiotic treatment

Exclusion Criteria

  • > 50 ml residual urine
  • neurological bladder disease
  • known neoplasia, kidney stone or urinary tract abnormalities
  • use og indwelling catheter
  • pregnancy
  • diabetes
  • infrequent voiding pattern
  • symptoms that indicate interstitial cystitis
  • creatinin > 250 micmol/L
  • participating in other clinical trial

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Akershus
  • Collaborator
    • St. Olavs Hospital
  • Provider of Information About this Clinical Study
    • MD Caroline Ursin Skagemo, Urologisk avdeling, Akershus Universitetssykehus HF
  • Overall Official(s)
    • Caroline U Skagemo, MD, Principal Investigator, Akershus Universitetssykehus HF
    • Gunn Iren Meling, PhD. MD, Study Director, Akershus Universitetssykehus HF
  • Overall Contact(s)
    • Caroline Ursin Skagemo, MD, +47 02900111, cask@ahus.no

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