Evidence of the benefit of SYN-53 in the treatment of patients with allergic rhinoconjunctivitis due to grass pollen and associated symptoms
| ISRCTN | ISRCTN99056955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99056955 |
- Submission date
- 01/02/2021
- Registration date
- 05/02/2021
- Last edited
- 05/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr David Rietbrock
Public
Public
FUTRUE
Am Haag 14
Gräfelfing
82166
Germany
| Phone | Not provided |
|---|---|
| studienkoordination@synformulas.com |
Mr David Rietbrock
Scientific
Scientific
FUTRUE
Am Haag 14
Gräfelfing
82166
Germany
| Phone | Not provided |
|---|---|
| studienkoordination@synformulas.com |
Study information
| Study design | Monocentric randomized double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evidence of the benefit of SYN-53 in a double-blind, placebo-controlled monocentric study in the treatment of patients with allergic rhinoconjunctivitis due to grass pollen and associated symptoms |
| Study acronym | SYN-53 |
| Study hypothesis | The reduction of the total symptom score is significantly greater after consumption of SYN-53 than after consumption of placebo |
| Ethics approval(s) | Approved 18/09/2020, Ethik-Kommission der Charite Berlin (Ethics commission of Charite Berlin, Charitèplatz 1, 10117 Berlin, Germany; +49 30 450 517 222; ethikkommission@charite.de), ref: EA1/216/20 |
| Condition | Allergic rhinoconjunctivitis caused by grass pollen |
| Intervention | Treatment: 3 capsules (oral administration) of SYN-53 per day for 3 days after each exposure Control: 3 capsules of placebo (oral administration) per day for 3 days after each exposure Randomisation: 1:1 block randomisation by sealed envelope. Placebo and verum are indistinguishable from each other. Study Design: 1. Screening 2. Baseline exposure 3. Repeated biweekly exposure in an allergen exposure chamber (AEC) |
| Intervention type | Supplement |
| Primary outcome measure | Symptoms are measured using the Total Symptom Score (TSS, max. 24 Points) = Total Nose Symptom Score (TNSS, max. 12 Points) + Total Eye Symptom Score (TESS, max. 12 Points) at baseline and at repeated biweekly intervals (max. 3 exposures) |
| Secondary outcome measures | Measured at baseline and at repeated biweekly intervals (max. 3 exposures) unless otherwise noted: 1. Eye Symptoms using the Max. Total Eye Symptom Score (TESS) 2. Nasal Symptoms using the Max. Total Nasal Symptom Score (TNSS) 3. Bronchial Symptoms using the Max. Total Bronchial Symptom Score (TBSS) 4. Other Symptoms using the Total Other Symptom Score (TOSS) 5. Well-being using the Visual Analogue Scale (VAS) 6. Peak Nasal Inspiratory Flow (PNIF) before and after each exposure 7. Spirometrie (FEV1, FEV1/FVC, MEF25-75) before and after each exposure 8. Amount of nasal secretion by weighing handkerchiefs before and after each exposure 9. Use of emergency medications and/or emergency case management 10. Number of incidents and number of subjects with adverse events related to ingestion of the dietary supplement SYN-53 after each exposure 11. Number of incidents and number of individuals with late reactions and/or adverse events related to exposure after each exposure |
| Overall study start date | 07/07/2020 |
| Overall study end date | 27/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Participant inclusion criteria | 1. Persons of either sex between 18 and 65 years of age 2. Oral and written consent 3. Patients with clinically relevant sensitization to grass pollen and allergic symptoms for at least 2 years 4. Positive skin prick test (SPT) to grass pollen 5. Proven response to exposure to grass pollen in the AEC 6. Patients who agree to undergo all examinations and procedures mentioned in the study protocol 7. Patients who are fully conversant with the German language |
| Participant exclusion criteria | 1. Persons under 18 years of age 2. Acute infections 3. Current cancer diagnosis/cancer within the last 5 years or autoimmune disease 4. Gastrointestinal disorders that may affect the absorption and processing of orally ingested substances, such as congenital gastrointestinal malformations or acute gastrointestinal infections 5. Severe forms of the following underlying chronic diseases: neurological diseases, metabolic diseases, severe asthma or respiratory obstruction, congenital anomalies of the heart, gastrointestinal system, or lungs 6. Patients with an FEV1 <70% (predicted value) prior to allergen exposure 7. Mental illnesses (e.g., depression) in the last 2 years 8. Eating disorders (e.g. bulimia, anorexia nervosa) in the last 2 years 9. Pregnant or breastfeeding female subjects 10. Alcohol or drug abuse 11. Clinically relevant hypersensitivity to any of the ingredients of SYN-53 12. Participation in clinical trials in the last 3 months 13. Placement in an institution due to court or official orders 14. Contraindications to epinephrine and/or other emergency medications (especially cetirizine) 15. Hyposensitization within the last 5 years against grass pollen 16. Heavy smokers (according to WHO definition more than 20 cigarettes daily) 17. Use of certain medications before V1 as well as during the study: 17.1. Decongestant nasal drops (3 days) 17.2. Antihistamines (5 days) 17.3. Anti-allergic eye drops and nasal sprays (1 week) 17.4. Topical steroids (2 weeks) 17.5. Systemic corticosteroids (3 weeks) 17.6. Probiotics (4 weeks) 17.7. Antibiotics (4 weeks) |
| Recruitment start date | 18/09/2020 |
| Recruitment end date | 12/10/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
ECARF Institute GmbH
Robert-Koch-Platz 7
Berlin
10115
Germany
Berlin
10115
Germany
Sponsor information
Synformulas GmbH
Industry
Industry
Am Haag 14
Gräfelfing
82166
Germany
| Phone | +49 (0)89 78 79 790 78 |
|---|---|
| info@synformulas.de | |
| Website | https://synformulas.com/ |
Funders
Funder type
Industry
Synformulas GmbH
No information available
Results and Publications
| Intention to publish date | 27/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
03/02/2021: Trial’s existence confirmed by Ethik-Kommission der Charite Berlin.
