Clinical trial NCT00781625: Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI's)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infections
Keywords: probiotics
QoL
inflammation
nutritional factors
prophylactic aid
Lactobacillus rhamnosus GR-1
Lactobacillus reuteri RC-14
Recurrent lower UTI in women
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Karolinska Institutet
name: University of Oslo
name: Folkehelsa
First posted: 2008-10-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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 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

Primary outcomes:
measure: Reduction in number og episodes og lower UTI
timeFrame: 6 months intervention period
measure: Improvement of QOL
timeFrame: 6 months intervention period
Secondary outcomes:
measure: Improvement of immune function
timeFrame: 6 months
measure: Effects are non-dependant og nutritional status
timeFrame: 6 month2
measure: Effects are non-dependant of known factors contributing til UTI's
timeFrame: 6 months
measure: Decreases inflammation in the urinary bladder epithelium
timeFrame: 6 months
measure: Normalizes vaginal microflora
timeFrame: 6 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF
state: Akershus
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: Akershus Universitetssykehus HF
name: Caroline U Skagemo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akershus Universitetssykehus HF
name: Gunn Iren Meling, PhD. MD
role: STUDY_DIRECTOR
References: