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

Sponsors and Collaborators:	University Hospital, Akershus St. Olavs Hospital Karolinska Institutet University of Oslo Folkehelsa
Information provided by:	University Hospital, Akershus
ClinicalTrials.gov Identifier:	NCT00781625

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

MedlinePlus related topics: Diets Urinary Tract Infections

Drug Information available for: Methenamine Methenamine mandelate Methenamine hippurate

U.S. FDA Resources

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

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
Probiotic vaginal capsules: Active Comparator 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: Placebo Comparator 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
Probiotic oral capsules: Active Comparator 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

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
St.Olavs Hospital	Active, not recruiting
Trondheim, Norway, 7006
Norway, Akershus
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

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:	Urologisk avdeling, Akershus Universitetssykehus HF ( MD Caroline Ursin Skagemo )
Study ID Numbers:	S-08458d (REK), 08/7922(Shdir)
Study First Received:	October 28, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00781625
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Directorate for Health and Social Affairs; 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

Study placed in the following topic categories:

Titanium dioxide
Urologic Diseases
Urinary Tract Infections

Cystitis
Recurrence
Inflammation

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on February 12, 2009