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

Primary Purpose

Urinary Tract Infections

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
UREX-cap-5
UREX-cap-5
Placebo Y cap G-3
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring probiotics, QoL, inflammation, nutritional factors, prophylactic aid, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Recurrent lower UTI in women

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Akershus Universitetssykehus HFRecruiting
  • St.Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Probiotic vaginal capsules

placebo

Probiotic oral capsules

Arm Description

Probiotic vaginal capsule, placebo oral capsule

placebo oral capsule, placebo vaginal capsule

Probiotic oral capsules, placebo vaginal capsules

Outcomes

Primary Outcome Measures

Reduction in number og episodes og lower UTI
Improvement of QOL

Secondary Outcome Measures

Improvement of immune function
Effects are non-dependant og nutritional status
Effects are non-dependant of known factors contributing til UTI's
Decreases inflammation in the urinary bladder epithelium
Normalizes vaginal microflora

Full Information

First Posted
October 28, 2008
Last Updated
October 29, 2008
Sponsor
University Hospital, Akershus
Collaborators
St. Olavs Hospital, Karolinska Institutet, University of Oslo, Folkehelsa
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1. Study Identification

Unique Protocol Identification Number
NCT00781625
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Akershus
Collaborators
St. Olavs Hospital, Karolinska Institutet, University of Oslo, Folkehelsa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
probiotics, QoL, inflammation, nutritional factors, prophylactic aid, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Recurrent lower UTI in women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic vaginal capsules
Arm Type
Active Comparator
Arm Description
Probiotic vaginal capsule, placebo oral capsule
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo oral capsule, placebo vaginal capsule
Arm Title
Probiotic oral capsules
Arm Type
Active Comparator
Arm Description
Probiotic oral capsules, placebo vaginal capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
UREX-cap-5
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
UREX-cap-5
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Y cap G-3
Intervention Description
Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months
Primary Outcome Measure Information:
Title
Reduction in number og episodes og lower UTI
Time Frame
6 months intervention period
Title
Improvement of QOL
Time Frame
6 months intervention period
Secondary Outcome Measure Information:
Title
Improvement of immune function
Time Frame
6 months
Title
Effects are non-dependant og nutritional status
Time Frame
6 month2
Title
Effects are non-dependant of known factors contributing til UTI's
Time Frame
6 months
Title
Decreases inflammation in the urinary bladder epithelium
Time Frame
6 months
Title
Normalizes vaginal microflora
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Ursin Skagemo, MD
Phone
+47 02900111
Email
cask@ahus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Gunn Iren Meling, PhD, MD
Phone
+47 02900111
Ext
69298
Email
gmel@ahus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline U Skagemo, MD
Organizational Affiliation
Akershus Universitetssykehus HF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunn Iren Meling, PhD. MD
Organizational Affiliation
Akershus Universitetssykehus HF
Official's Role
Study Director
Facility Information:
Facility Name
Akershus Universitetssykehus HF
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline U Skagemo, MD
Phone
+47 02900111
Email
cask@ahus.no
First Name & Middle Initial & Last Name & Degree
Gunn Iren Meling, PhD, MD
Phone
+47 02900 111
Email
gmel@ahus.no
First Name & Middle Initial & Last Name & Degree
Caroline U Skagemo, MD
Facility Name
St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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