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Sponsors and Collaborators: |
University Hospital, Akershus St. Olavs Hospital Karolinska Institutet University of Oslo Folkehelsa |
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Information provided by: | University Hospital, Akershus |
ClinicalTrials.gov Identifier: | NCT00781625 |
To investigate if administration of probiotics, either orally or vaginally,
Condition | Intervention |
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Urinary Tract Infections |
Dietary Supplement: UREX-cap-5 Dietary Supplement: Placebo Y cap G-3 |
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. |
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 |
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Probiotic vaginal capsules: Active Comparator
Probiotic vaginal capsule, placebo oral capsule
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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.
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placebo: Placebo Comparator
placebo oral capsule, placebo vaginal capsule
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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
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Probiotic oral capsules: Active Comparator
Probiotic oral capsules, placebo vaginal capsules
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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.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Caroline Ursin Skagemo, MD | +47 02900111 | cask@ahus.no |
Contact: Gunn Iren Meling, PhD, MD | +47 02900111 ext 69298 | gmel@ahus.no |
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 |
Principal Investigator: | Caroline U Skagemo, MD | Akershus Universitetssykehus HF |
Study Director: | Gunn Iren Meling, PhD. MD | Akershus Universitetssykehus HF |
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 |
probiotics QoL inflammation nutritional factors |
prophylactic aid Lactobacillus rhamnosus GR-1 Lactobacillus reuteri RC-14 Recurrent lower UTI in women |
Titanium dioxide Urologic Diseases Urinary Tract Infections |
Cystitis Recurrence Inflammation |
Communicable Diseases Infection |