Improved immune defense by a proprietary larch arabinogalactan
| ISRCTN | ISRCTN41183655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41183655 |
| Secondary identifying numbers | LON/K/01309 |
- Submission date
- 18/05/2012
- Registration date
- 08/06/2012
- Last edited
- 05/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The common cold is a mild viral infection of the nose, throat, sinuses and upper airways. The aim of this study is to find out whether ResistAid™ (arabinogalactan), a sugar derived from larch trees, helps to decrease the incidence of the common cold by boosting the immune system.
Who can participate?
Healthy men and women aged 18-70 who have had at least three common cold infections within the last 6 months
What does the study involve?
Participants are randomly allocated to consume a sachet of ResistAid™ or placebo (dummy drug) daily with breakfast over a course of 12 weeks. Participants attend three visits: at the start of the study, after 6 weeks and at the end after 12 weeks. Additionally, if a cold occurs, there are two extra visits at the start and on the fifth day of the cold. Participants recorded their cold symptoms in a diary. The number, severity and duration of colds 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?
Analyze & Realize AG (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?
Lonza Ltd (Switzerland)
Who is the main contact?
Dr Linda Böhme
lboehme@analyze-realize.com
Contact information
Scientific
Analyze & Realize AG
Waldseeweg 6
Berlin
13467
Germany
| Phone | +49 (0)30 4000 8152 |
|---|---|
| lboehme@analyze-realize.com |
Study information
| Study design | Double-blind randomized placebo-controlled multi-centre clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Double-blind, randomized, placebo-controlled clinical study to evaluate the immune-enhancing properties of a proprietary larch arabinogalactan (ResistAid™) by assessing the incidence of common cold |
| Study hypothesis | The incidence of common cold during the study period is expected to be decreased in the verum study arm compared to the placebo study arm. |
| Ethics approval(s) | Charité (Universitaetsmedizin Berlin, Campus Charité Mitte), 12/10/2010, ref: EA1/208/10 |
| Condition | Immune function |
| Intervention | ResistAid™ study arm compared to placebo study arm Intake of one sachet (4.5g) daily with breakfast. A total of three basic visits were performed: Visit 1 at study start (=baseline), Control Visit after 6 weeks and Termination Visit after 12 weeks. Additionally, if a cold episode occurred, an Episode Visit was performed at start and on the 5th day of each 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 second Episode Visit 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. Further, the safety laboratory parameters as well as special laboratory parameters (leukocyte differentiation) were assessed at baseline and end of study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Larch arabinogalactan (ResistAid™) |
| Primary outcome measure | Number of cold episodes during the study period |
| Secondary outcome measures | 1. Duration of cold episodes (based on subject diary) 2. Episode intensity assessed per change of the total sum score after 5 days compared to start of episode (first Episode Visit), based on case report form (CRF) and subject diary 3. Episode intensity at start of episode (sum score on Day 1 based on subject diary, i.e. at first Episode Visit based on CRF) 4. Global assessment of efficacy and tolerability 5. Assessment of adverse events 6. Assessment of laboratory parameters including leucocyte differentiation 7. Assessment of eating habits based on a 3-day-record |
| Overall study start date | 13/10/2010 |
| Overall study end date | 05/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | 1. Age 18 - 70 years (child-bearing females had to agree to use appropriate birth control methods) 2. Recurrent infections of upper airways (at least 3 episodes in half-year according to subjects statement) 3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply |
| Participant exclusion criteria | 1. Acute infection of the upper airways 2. Chronic upper airways disease (e.g. chronic bronchitis or asthma) 3. Suspected influenza or swine flu 4. Body temperature above 38°C 5. Vaccination against influenza or swine flu within 21 days before study start 6. Serious organ or systemic diseases 7. Body mass index above 30 8. Clinically significant abnormal laboratory parameters (values outside of reference range) 9. Known sensitivity to the ingredients of the investigational product 10. Inborn or acquired immune deficiency disease (e.g. HIV infection) 11. Pregnancy and nursing 12. Use of following medication: 12.1. Immunosuppressive agents 12.2. Immunostimulating agents, e.g. Echinacea 12.3. Local oral and pharyngeal treatment 12.4. Antibiotics within 14 days before study start 13. Drugs, alcohol and medical abuse 14. Use of prebiotics and probiotics (e.g. yogurt, drinks, supplements) 15. Participation in another clinical study at or within 30 days before study start 16. Inability to comply with study requirements |
| Recruitment start date | 13/10/2010 |
| Recruitment end date | 05/05/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
13467
Germany
Sponsor information
Industry
Münchensteinerstrasse 38
Basel
4002
Switzerland
| ulla.freitas@lonza.com | |
| Website | http://www.lonza.com |
"ROR" |
https://ror.org/002adfz67 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
Editorial Notes
05/10/2016: Plain English summary added.
