Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI's)
Recruitment status was Recruiting
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Purpose
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
| Condition | Intervention |
|---|---|
|
Urinary Tract Infections |
Dietary Supplement: UREX-cap-5 Dietary Supplement: Placebo Y cap G-3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Probiotics/Lactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women. A Randomized, Prospective, Double-Blinded, Placebo Controlled, Multi-Center Study. |
- Reduction in number og episodes og lower UTI [ Time Frame: 6 months intervention period ] [ Designated as safety issue: No ]
- Improvement of QOL [ Time Frame: 6 months intervention period ] [ Designated as safety issue: No ]
- Improvement of immune function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effects are non-dependant og nutritional status [ Time Frame: 6 month2 ] [ Designated as safety issue: No ]
- Effects are non-dependant of known factors contributing til UTI's [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Decreases inflammation in the urinary bladder epithelium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Normalizes vaginal microflora [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: Probiotic vaginal capsules
Probiotic vaginal capsule, placebo oral capsule
|
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.
|
|
Placebo Comparator: placebo
placebo oral capsule, placebo vaginal capsule
|
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
|
|
Active Comparator: Probiotic oral capsules
Probiotic oral capsules, placebo vaginal capsules
|
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.
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| Contact: Caroline Ursin Skagemo, MD | +47 02900111 | cask@ahus.no |
| Contact: Gunn Iren Meling, PhD, MD | +47 02900111 ext 69298 | gmel@ahus.no |
| Norway | |
| 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 | |
| St.Olavs Hospital | Active, not recruiting |
| Trondheim, Norway, 7006 | |
| Principal Investigator: | Caroline U Skagemo, MD | Akershus Universitetssykehus HF |
| Study Director: | Gunn Iren Meling, PhD. MD | Akershus Universitetssykehus HF |
More Information
No publications provided
| Responsible Party: | MD Caroline Ursin Skagemo, Urologisk avdeling, Akershus Universitetssykehus HF |
| ClinicalTrials.gov Identifier: | NCT00781625 History of Changes |
| Other Study ID Numbers: | S-08458d (REK), 08/7922(Shdir) |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 29, 2008 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Directorate of Health Norway: Norwegian Medicines Agency |
Keywords provided by University Hospital, Akershus:
|
probiotics QoL inflammation nutritional factors |
prophylactic aid Lactobacillus rhamnosus GR-1 Lactobacillus reuteri RC-14 Recurrent lower UTI in women |
Additional relevant MeSH terms:
|
Urinary Tract Infections Infection Urologic Diseases Methenamine hippurate Anti-Infective Agents, Urinary |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Renal Agents |
ClinicalTrials.gov processed this record on May 16, 2013