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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00781625
• Other study ID #: S-08458d (REK)
• Secondary ID: 08/7922(Shdir)
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2008
• Last updated: October 29, 2008
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: University Hospital, Akershus
• Contact: Caroline Ursin Skagemo, MD
• Phone: +47 02900111
• Email: cask[@]ahus.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of HealthNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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.
• 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 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

Locations

Country	Name	City	State
Norway	Akershus Universitetssykehus HF	Lørenskog	Akershus
Norway	St.Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Akershus	Folkehelsa, Karolinska Institutet, St. Olavs Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number og episodes og lower UTI		6 months intervention period	No
Primary	Improvement of QOL		6 months intervention period	No
Secondary	Improvement of immune function		6 months	No
Secondary	Effects are non-dependant og nutritional status		6 month2	No
Secondary	Effects are non-dependant of known factors contributing til UTI's		6 months	No
Secondary	Decreases inflammation in the urinary bladder epithelium		6 months	No
Secondary	Normalizes vaginal microflora		6 months	No