Immune function Infections and Infestations Acute upper respiratory infections
Conditions
Interventions
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 af
Sponsors
Lonza Ltd (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
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 subject?s statement) 3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cold episodes during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed