Condition category
Signs and Symptoms
Date applied
05/11/2012
Date assigned
16/11/2012
Last edited
16/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Sponsor details

Kreutzwaldi str 1
Tartu
51014
Estonia

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes