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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00781625
Enrollment
120
Registered
2008-10-29
Start date
2008-10-31
Completion date
2010-12-31
Last updated
2008-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIETARY_SUPPLEMENTUREX-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.

DIETARY_SUPPLEMENTPlacebo 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

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Folkehelsa
CollaboratorUNKNOWN
University Hospital, Akershus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction in number og episodes og lower UTI6 months intervention period
Improvement of QOL6 months intervention period

Secondary

MeasureTime frame
Effects are non-dependant of known factors contributing til UTI's6 months
Improvement of immune function6 months
Normalizes vaginal microflora6 months
Decreases inflammation in the urinary bladder epithelium6 months
Effects are non-dependant og nutritional status6 month2

Countries

Norway

Contacts

Primary ContactCaroline Ursin Skagemo, MD
cask@ahus.no+47 02900111
Backup ContactGunn Iren Meling, PhD, MD
gmel@ahus.no+47 02900111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026