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

Condition(s) targeted: Urinary Tract Infections

Intervention: UREX-cap-5 (Dietary Supplement); UREX-cap-5 (Dietary Supplement); Placebo Y cap G-3 (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Akershus

Official(s) and/or principal investigator(s):
Caroline U Skagemo, MD, Principal Investigator, Affiliation: Akershus Universitetssykehus HF
Gunn Iren Meling, PhD. MD, Study Director, Affiliation: Akershus Universitetssykehus HF

Overall contact:
Caroline Ursin Skagemo, MD, Phone: +47 02900111, Email: cask@ahus.no

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

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

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

Primary outcome:

Reduction in number og episodes og lower UTI

Improvement of QOL

Secondary outcome:

Improvement of immune function

Effects are non-dependant og nutritional status

Effects are non-dependant of known factors contributing til UTI's

Decreases inflammation in the urinary bladder epithelium

Normalizes vaginal microflora

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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

Caroline Ursin Skagemo, MD, Phone: +47 02900111, Email: cask@ahus.no

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

Akershus Universitetssykehus HF, Lørenskog, Akershus 1478, Norway; Recruiting
Caroline U Skagemo, MD, Phone: +47 02900111, Email: cask@ahus.no
Gunn Iren Meling, PhD, MD, Phone: +47 02900 111, Email: gmel@ahus.no
Caroline U Skagemo, MD, Principal Investigator

Starting date: October 2008
Last updated: October 29, 2008