NCT00781625

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.2 years

First QC Date

October 28, 2008

Last Update Submit

October 29, 2008

Conditions

Urinary Tract Infections

Keywords

probioticsQoLinflammationnutritional factorsprophylactic aidLactobacillus rhamnosus GR-1Lactobacillus reuteri RC-14Recurrent lower UTI in women

Outcome Measures

Primary Outcomes (2)

  • Reduction in number og episodes og lower UTI

    6 months intervention period

  • Improvement of QOL

    6 months intervention period

Secondary Outcomes (5)

  • 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

    6 months

  • Decreases inflammation in the urinary bladder epithelium

    6 months

  • Normalizes vaginal microflora

    6 months

Study Arms (3)

Probiotic vaginal capsules

ACTIVE COMPARATOR

Probiotic vaginal capsule, placebo oral capsule

Dietary Supplement: UREX-cap-5

placebo

PLACEBO COMPARATOR

placebo oral capsule, placebo vaginal capsule

Dietary Supplement: Placebo Y cap G-3

Probiotic oral capsules

ACTIVE COMPARATOR

Probiotic oral capsules, placebo vaginal capsules

Dietary Supplement: UREX-cap-5

Interventions

UREX-cap-5DIETARY_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.

Probiotic oral capsules
Placebo Y cap G-3DIETARY_SUPPLEMENT

Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 18-70 years old
  • spontaneous urination
  • \> 3 UTI's previous year
  • no ongoing prophylactic antibiotic treatment

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus Universitetssykehus HF

Lørenskog, Akershus, 1478, Norway

RECRUITING

St.Olavs Hospital

Trondheim, 7006, Norway

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Urinary Tract InfectionsInflammation

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline U Skagemo, MD

    Akershus Universitetssykehus HF

    PRINCIPAL INVESTIGATOR

  • Gunn Iren Meling, PhD. MD

    Akershus Universitetssykehus HF

    STUDY DIRECTOR

Central Study Contacts

Caroline Ursin Skagemo, MD

CONTACT

+47 02900111cask@ahus.no

Gunn Iren Meling, PhD, MD

CONTACT

+47 02900111gmel@ahus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

NO(2)