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

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

Conditions

• Urinary Tract Infections

Interventions

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.

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.

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

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Folkehelsa

  collaborator UNKNOWN

• University Hospital, Akershus

  lead OTHER

Principal Investigators

• Caroline U Skagemo, MD · Akershus Universitetssykehus HF

• Gunn Iren Meling, PhD. MD · Akershus Universitetssykehus HF

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2009-12-31

Completion

2010-12-31

Countries

• Norway

Study Locations