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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University Hospital, Akershus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St. Olavs Hospital
Karolinska Institutet
University of Oslo
Folkehelsa
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT00781625
First received: October 28, 2008
Last updated: October 29, 2008
Last verified: October 2008
  Purpose

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

Condition Intervention
Urinary Tract Infections
Dietary Supplement: UREX-cap-5
Dietary Supplement: Placebo Y cap G-3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics/Lactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women. A Randomized, Prospective, Double-Blinded, Placebo Controlled, Multi-Center Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Reduction in number og episodes og lower UTI [ Time Frame: 6 months intervention period ] [ Designated as safety issue: No ]
  • Improvement of QOL [ Time Frame: 6 months intervention period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of immune function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effects are non-dependant og nutritional status [ Time Frame: 6 month2 ] [ Designated as safety issue: No ]
  • Effects are non-dependant of known factors contributing til UTI's [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Decreases inflammation in the urinary bladder epithelium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Normalizes vaginal microflora [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic vaginal capsules
Probiotic vaginal capsule, placebo oral capsule
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.
Placebo Comparator: placebo
placebo oral capsule, placebo vaginal capsule
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
Active Comparator: Probiotic oral capsules
Probiotic oral capsules, placebo vaginal capsules
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781625

Contacts
Contact: Caroline Ursin Skagemo, MD +47 02900111 cask@ahus.no
Contact: Gunn Iren Meling, PhD, MD +47 02900111 ext 69298 gmel@ahus.no

Locations
Norway
Akershus Universitetssykehus HF Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Caroline U Skagemo, MD    +47 02900111    cask@ahus.no   
Contact: Gunn Iren Meling, PhD, MD    +47 02900 111    gmel@ahus.no   
Principal Investigator: Caroline U Skagemo, MD         
St.Olavs Hospital Active, not recruiting
Trondheim, Norway, 7006
Sponsors and Collaborators
University Hospital, Akershus
St. Olavs Hospital
Karolinska Institutet
University of Oslo
Folkehelsa
Investigators
Principal Investigator: Caroline U Skagemo, MD Akershus Universitetssykehus HF
Study Director: Gunn Iren Meling, PhD. MD Akershus Universitetssykehus HF
  More Information

No publications provided

Responsible Party: MD Caroline Ursin Skagemo, Urologisk avdeling, Akershus Universitetssykehus HF
ClinicalTrials.gov Identifier: NCT00781625     History of Changes
Other Study ID Numbers: S-08458d (REK), 08/7922(Shdir)
Study First Received: October 28, 2008
Last Updated: October 29, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health
Norway: Norwegian Medicines Agency

Keywords provided by University Hospital, Akershus:
probiotics
QoL
inflammation
nutritional factors
prophylactic aid
Lactobacillus rhamnosus GR-1
Lactobacillus reuteri RC-14
Recurrent lower UTI in women

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014