Plain English Summary
Background and study aims
Beta-glucans are sugars found in the cell walls of brewers’ yeast, fungi, and some bacteria. Due to its immune system stimulating properties, beta-glucan may have an effect on the incidence of common cold (a mild viral infection of the nose, throat, sinuses and upper airways). The aim of this study is to investigate the effectiveness and safety of the beta-glucan extract Yestimun® in people who are more susceptible to the common cold.
Who can participate?
Healthy males and females aged 18-70 who have had at least three common cold infections within the last 6 months
What does the study involve?
During the study period of 16 weeks, participants are randomly allocated to consume a capsule of either Yestimun or a placebo (dummy tablet) each with breakfast and supper. Participants attend three visits: at the start of the study, after 8 weeks and at the end after 16 weeks. The number, severity and duration of colds, use of antibiotics and analgesics (painkillers), and side effects are assessed in both groups.
What are the possible benefits and risks of participating?
Participants may benefit from a reduced incidence of common cold, and there are no risks expected.
Where is the study run from?
The study is conducted in seven study centres in Berlin, Germany
When is the study starting and how long is it expected to run for?
October 2010 to May 2011
Who is funding the study?
Leiber GmbH (Germany)
Who is the main contact?
Dr Annegret Auinger
aauinger@analyze-realize.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Annegret Auinger
ORCID ID
Contact details
analyze & realize ag
Waldseeweg 6
Berlin
13467
Germany
+49 (0)30 4000 8156
aauinger@analyze-realize.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LEI/K/00810
Study information
Scientific title
Double-blind, randomized, placebo-controlled clinical study to evaluate efficacy and safety of Yestimun® in subjects with increased susceptibility to common cold
Acronym
Study hypothesis
Due to the immune-modulating properties of yeast beta-glucan, the number of common cold episodes is expected to be decreased during the study period in the verum study arm compared to the placebo study arm.
Ethics approval
Charité - Universitaetsmedizin Berlin, Campus Charité Mitte), 14/10/2010, ref: EA1/221/10
Study design
Double-blind randomized placebo-controlled multi-centre clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Immune function
Intervention
Subjects were randomly assigned to receive a total of 900 mg of either Yestimun® or placebo, each provided in two capsules per day, which were consumed at breakfast and supper.
During the study period of 16 weeks, a total of three routine visits were performed: at baseline, after 8 weeks and at the end after 16 weeks. In addition, one episode visit was conducted on the 5th day of each cold episode.
A cold episode was defined by having (any of) the following symptoms: headache, joint pain, sore throat, difficulty swallowing, hoarseness, coughing, watery nasal discharge, nasal congestion, cold related sleeping difficulties, and body temperature above 38°C. During an episode, the subjects recorded and assessed their cold symptoms in the subject diary, for a period of 14 days. The diaries were checked by the investigators at the Episode Visits of each episode.
At study end (Termination Visit), the investigators and the subjects assessed the global efficacy and tolerability of the investigational product. At the start and end of the study, subjects recorded their eating habits in a diet diary.
Intervention type
Drug
Phase
Not Applicable
Drug names
Yestimun®
Primary outcome measures
Reduction of number of cold episodes during the study period in the Yestimun® study arm compared to placebo study arm
Secondary outcome measures
1. Severity of cold episodes (total sum score during the entire episode)
2. Duration of cold episodes (based on subject diary)
3. Severity of colds at episode start (total score on day 1 and day 2)
4. Severity of colds on the day of the Episode Visit (CRF)
5. Use of antibiotics and analgesics (subject's diary)
6. Global assessment of efficacy and tolerability
7. Assessment of adverse events
8. Assessment of sick leave days
Overall trial start date
15/10/2010
Overall trial end date
12/05/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: ≥ 18 years (child-bearing females had to agree to use appropriate birth control methods)
2. At least three common cold infections within the last six months
3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
224
Participant exclusion criteria
1. Acute infection of the upper airways (e.g. acute bronchitis)
2. Chronic upper airway disease (e.g. chronic bronchitis, tonsillitis or asthma)
3. Chronic cough of any origin
4. Chronic rhinitis (vasomotor or allergic rhinitis)
5. Congenital or acquired immunodeficiency disease (e.g. HIV infection)
6. Acute or chronic diarrhea
7. Severe organ or systemic diseases
8. Suspected swine flu or influenza
9. Body temperature above 37.5°C
10. Vaccination against influenza or swine flu within 21 days prior to study start
11. Known hypersensitivity to ingredients of the investigational product
12. Pregnancy and lactation
13. Use of immunosuppressants
14. Use of immunostimulants (e.g. Echinacea) within the last 14 days prior to study start
15. Use of antibiotics within the last 14 days prior to study start
16. Alcohol/drug abuse; drug addiction
17. Simultaneous participation in another clinical trial or participation in a clinical trial within the last 4 weeks
18. Regular use of other yeast preparations
19. Incertainty regarding compliance
Recruitment start date
15/10/2010
Recruitment end date
12/05/2011
Locations
Countries of recruitment
Germany
Trial participating centre
analyze & realize ag
Berlin
13467
Germany
Sponsor information
Organisation
Leiber GmbH (Germany)
Sponsor details
Hafenstraße 24
Bramsche
49565
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Leiber GmbH (Germany)
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