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| ID | Type | Description | Link |
|---|---|---|---|
| 08/7922(Shdir) |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Karolinska Institutet | OTHER |
| University of Oslo | OTHER |
| Folkehelsa |
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To investigate if administration of probiotics, either orally or vaginally,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic vaginal capsules | Active Comparator | Probiotic vaginal capsule, placebo oral capsule |
|
| placebo | Placebo Comparator | placebo oral capsule, placebo vaginal capsule |
|
| Probiotic oral capsules | Active Comparator | Probiotic oral capsules, placebo vaginal capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UREX-cap-5 | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in number og episodes og lower UTI | 6 months intervention period | |
| Improvement of QOL | 6 months intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of immune function | 6 months | |
| Effects are non-dependant og nutritional status | 6 month2 | |
| Effects are non-dependant of known factors contributing til UTI's |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Ursin Skagemo, MD | Contact | +47 02900111 | cask@ahus.no | |
| Gunn Iren Meling, PhD, MD | Contact | +47 02900111 | 69298 | gmel@ahus.no |
| Name | Affiliation | Role |
|---|---|---|
| Caroline U Skagemo, MD | Akershus Universitetssykehus HF | Principal Investigator |
| Gunn Iren Meling, PhD. MD | Akershus Universitetssykehus HF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus Universitetssykehus HF | Recruiting | Lørenskog | Akershus | 1478 | Norway |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| UNKNOWN |
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| UREX-cap-5 | Dietary Supplement | 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 | Dietary Supplement | Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months |
|
| 6 months |
| Decreases inflammation in the urinary bladder epithelium | 6 months |
| Normalizes vaginal microflora | 6 months |
| St.Olavs Hospital | Active, not recruiting | Trondheim | 7006 | Norway |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |