Safety and efficacy of insoluble (1,3)-(1,6)-beta-glucan made from brewers? yeast (Saccharomyces cerevisiae)

Not Applicable

Completed

• Conditions: Immune function; Infections and Infestations; Acute nasopharyngitis [common cold]

• Registration Number: ISRCTN16094368
• Lead Sponsor: eiber GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-03
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 224

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of number of cold episodes during the study period in the Yestimun® study arm compared to placebo study arm

Secondary Outcome Measures

Name	Time	Method
1. Severity of cold episodes (total sum score during the entire episode)<br>2. Duration of cold episodes (based on subject diary)<br>3. Severity of colds at episode start (total score on day 1 and day 2)<br>4. Severity of colds on the day of the Episode Visit (CRF)<br>5. Use of antibiotics and analgesics (subject's diary)<br>6. Global assessment of efficacy and tolerability<br>7. Assessment of adverse events<br>8. Assessment of sick leave days