Urinary Tract InfectionsNCT00781625
Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections (UTI's)
A study testing UREX-cap-5 in people with Urinary Tract Infections, run by University Hospital, Akershus at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- UREX-cap-5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 18-70 years old
- spontaneous urination
- > 3 UTI's previous year
- no ongoing prophylactic antibiotic treatment
Who cannot join
- > 50 ml residual urine
- neurological bladder disease
- known neoplasia, kidney stone or urinary tract abnormalities
- use og indwelling catheter
- pregnancy
- diabetes
Show all 10Show fewer
- infrequent voiding pattern
- symptoms that indicate interstitial cystitis
- creatinin > 250 micmol/L
- participating in other clinical trial
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 1 recruiting
- Recruiting
Akershus Universitetssykehus HF
Lørenskog, Akershus, 1478
Caroline U Skagemo, MD, +47 02900111, cask@ahus.no
Gunn Iren Meling, PhD, MD, +47 02900 111, gmel@ahus.no
- Active, not recruiting
St.Olavs Hospital
Trondheim, 7006
About this study
Official title: Probiotics/Lactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women. A Randomized, Prospective, Double-Blinded, Placebo Controlled, Multi-Center Study.
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
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- UREX-cap-5, Placebo Y cap G-3
- Keywords
- probiotics, QoL, inflammation, nutritional factors, prophylactic aid, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Recurrent lower UTI in women
- Medical subject headings
- Urinary Tract Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Probiotic vaginal capsules | Active comparator | Probiotic vaginal capsule, placebo oral capsule Receives: Dietary Supplement: UREX-cap-5 |
| placebo | Placebo comparator | placebo oral capsule, placebo vaginal capsule Receives: Dietary Supplement: Placebo Y cap G-3 |
| Probiotic oral capsules | Active comparator | Probiotic oral capsules, placebo vaginal capsules Receives: Dietary Supplement: UREX-cap-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number og episodes og lower UTI
Measured: 6 months intervention period
Improvement of QOL
Measured: 6 months intervention period
Secondary outcomes (5)
Improvement of immune function
Measured: 6 months
Effects are non-dependant og nutritional status
Measured: 6 month2
Effects are non-dependant of known factors contributing til UTI's
Measured: 6 months
Decreases inflammation in the urinary bladder epithelium
Measured: 6 months
Normalizes vaginal microflora
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Karolinska Institutet, University of Oslo, Folkehelsa
- Investigators
- Caroline U Skagemo, MD, Principal investigator, Akershus Universitetssykehus HFGunn Iren Meling, PhD. MD, Study director, Akershus Universitetssykehus HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781625
- Sponsor's protocol ID
- S-08458d (REK)
- Other IDs
- 08/7922(Shdir)
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics/Lactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women. A Randomized, Prospective, Double-Blinded, Placebo Controlled, Multi-Center Study.
- ClinicalTrials.gov ID
- NCT00781625
- Acronym / sponsor ID
- S-08458d (REK)
- Conditions
- Urinary Tract Infections
- Keywords
- probiotics, QoL, inflammation, nutritional factors, prophylactic aid, Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC-14, Recurrent lower UTI in women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Karolinska Institutet, University of Oslo, Folkehelsa
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic vaginal capsules | Active comparator | Dietary Supplement: UREX-cap-5Probiotic vaginal capsule, placebo oral capsule |
| placebo | Placebo comparator | Dietary Supplement: Placebo Y cap G-3placebo oral capsule, placebo vaginal capsule |
| Probiotic oral capsules | Active comparator | Dietary Supplement: UREX-cap-5Probiotic oral capsules, placebo vaginal capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 18-70 years old
- spontaneous urination
- > 3 UTI's previous year
- no ongoing prophylactic antibiotic treatment
Key exclusion criteria (10 listed)
- > 50 ml residual urine
- neurological bladder disease
- known neoplasia, kidney stone or urinary tract abnormalities
- use og indwelling catheter
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UREX-cap-5Size 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 | Probiotic oral capsules |
| UREX-cap-5Size 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 | Probiotic vaginal capsules |
| Placebo Y cap G-3Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months | Dietary supplement | placebo |
Primary outcome
Reduction in number og episodes og lower UTI
Time frame: 6 months intervention period
Improvement of QOL
Time frame: 6 months intervention period
5 secondary outcomes
Improvement of immune function
Time frame: 6 months
Effects are non-dependant og nutritional status
Time frame: 6 month2
Effects are non-dependant of known factors contributing til UTI's
Time frame: 6 months
Decreases inflammation in the urinary bladder epithelium
Time frame: 6 months
Normalizes vaginal microflora
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline U Skagemo, MD principal investigator
Akershus Universitetssykehus HF
Gunn Iren Meling, PhD. MD study director
Akershus Universitetssykehus HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UREX-cap-5 in people with Urinary Tract Infections, run by University Hospital, Akershus at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Ursin Skagemo, MD (+47 02900111, cask@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number og episodes og lower UTI (time frame: 6 months intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.