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21 May 2013
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| [ Print-friendly version ] |
| Safety and efficacy of insoluble (1,3)-(1,6)-beta-glucan made from brewers’ yeast (Saccharomyces cerevisiae) |
| ISRCTN | ISRCTN16094368 |
| DOI | 10.1186/ISRCTN16094368 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Safety and efficacy of insoluble (1,3)-(1,6)-beta-glucan made from brewers’ yeast (Saccharomyces cerevisiae) |
| 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 | N/A |
| Serial number at source | LEI/K/00810 |
| 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. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Charité - Universitaetsmedizin Berlin, Campus Charité Mitte), 14 October 2010, ref: EA1/221/10 |
| Study design | Double-blind randomized placebo-controlled multi-centre clinical study |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Immune function |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 15/10/2010 |
| Anticipated end date | 12/05/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 224 |
| Interventions |
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. |
| Primary outcome measure(s) | Reduction of number of cold episodes during the study period in the Yestimun® study arm compared to placebo study arm |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Leiber GmbH (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Annegret Auinger |
| Address |
analyze & realize ag
Waldseeweg 6 |
| City/town | Berlin |
| Zip/Postcode | 13467 |
| Country | Germany |
| Tel | +49 30 4000 8156 |
| Fax | +49 30 4000 8456 |
| aauinger@analyze-realize.com | |
| Sponsor | Leiber GmbH (Germany) |
| Address | Hafenstraße 24 |
| City/town | Bramsche |
| Zip/Postcode | 49565 |
| Country | Germany |
| Sponsor website: | http://www.leibergmbh.de/ |
| Date applied | 30/07/2012 |
| Last edited | 03/08/2012 |
| Date ISRCTN assigned | 03/08/2012 |
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