Plain English Summary
Background and study aims
Prostate complaints, especially those associated with urination, are very common and reduce the quality of life of many men. Every non-pharmaceutical possibility (without the use of medication) to relieve urinary difficulties of men would be valued and it would be the best if a novel food product would have such effect. Thus there is a need for production and use of reliable, test-proven food products and dietary supplements with healthy properties. The use of lactic acid bacteria has been described beneficial for the treatment of urogenital infections, including prostate infection.
The initial studies showed that whey-based lactobacilli-treated special dairy products may have beneficial effect on men with moderate urination problems
Who can participate?
Men aged 45-75 yrs with moderate urination problems
What does the study involve?
Participants are randomly allocated to active or control group
Active group receives fermented whey-based drink (200g per day) for 4 weeks
Control group receives whey-based drink (200g per day) for 4 weeks
What are the possible benefits and risks of participating?
Study participants get assessment of their health status and if necessary, free consultation of a nutritionist and/or a specialist. This health assessment will provide more precise overall health status of participant.
The study causes minimal inconveniences to participants. As blood samples are taken by experienced nurse, the procedure is safe. However, there may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anemia.
Where is the study run from?
In andrology clinic in Tartu, Estonia
When is the study starting and how long is it expected to run for?
This study is starting in October 2012, it is expected to complete in January 2014.
Who is funding the study?
The study is funded by the grant from European Union (EU) Structural Funds
Who is the main contact?
Tiiu Kullisaar, PhD
tiiu.kullisaar@ut.ee
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tiiu Kullisaar
ORCID ID
Contact details
Ravila str 19
Tartu
50411
Estonia
+37 27 37 4314
Tiiu.Kullisaar@ut.ee
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
215/T-3
Study information
Scientific title
Efficacy of Whey-Based Dairy Products in the case of the Men With moderate Urination Problems (IPSS score < 19)
Acronym
WBDPMWUP
Study hypothesis
Whey-based lactobacilli-treated special whey products may have effect on men with moderate urination problems.
Ethics approval
Research Ethics Committee of the University of Tartu (UT REC), June, 14, 2012, ref:215/T-3
Study design
Randomized double-blind placebo controlled two armed study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Moderate urination problems
Intervention
Participants randomised to active or control group
1. Active intervention: fermented whey-based drink (200g per day)
2. Control: whey-based drink (200g per day)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Significant improvement of urinary problems of men with moderate urination problems (IPSS score 8-19)
Secondary outcome measures
Improvement / maintenance of clinical, biochemical, immunological and metabolic profile of men with moderate urination problems (IPSS score 8-19)
Overall trial start date
31/10/2012
Overall trial end date
26/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. A written informed consent#
2. Men (45-75 yrs of age) with moderate urination problems (IPSS score 8-19; International Prostate Symptome Score) having next indices:
2.1. Prostate-specific antigen (PSA) <10 ng/mL
2.2. Urinary flow rate 5-15 mL/s
2.3. Prostate volume <80 mL
2.4. Residue urine (measured abdominally) <300 mL
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
72
Participant exclusion criteria
1. Tumors of urinary tract, prostata, genital tract
2. Suffer from acute strong cholics of the urinary(genital) tract
3. Radio- or chemotherapy of pelvis
4. Prostate operation
5. Using α1- adrenoblocators within last two weeks
6. Using 5 α-reductase inhibitors within last 3 months
7. History of alcohol of drug abuse
Recruitment start date
31/10/2012
Recruitment end date
26/01/2014
Locations
Countries of recruitment
Estonia
Trial participating centre
Ravila str 19
Tartu
50411
Estonia
Funders
Funder type
Government
Funder name
European Union (EU) Structural Funds ref: EU30002
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary