Skip to content

Does ColdZyme mouth spray protect athletes against upper respiratory tract infection?

Does ColdZyme® Mouth Spray reduce upper respiratory tract infection incidence or duration in endurance athletes?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18133939
Enrollment
114
Registered
2022-09-27
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper respiratory tract infection (URTI) in healthy, free-living athletes Respiratory

Interventions

If they agree to take part, participants would be required to complete a health questionnaire to ensure they are suitable for participation, and to sign a consent form. Randomization: Fully double-

Sponsors

University of Kent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Endurance-trained, competitive athletes (e.g. long-distance runners, triathletes, cyclists), with a high training load (i.e. >5 hours planned training and/or activity per week)

Exclusion criteria

Exclusion criteria: 1. On long-term medication 2. Currently smoking 3. Allergic to any of the ingredients in ColdZyme 4. Currently using any medication (except for contraceptives), or food supplements 5. Currently using any other relevant products or supplements (nutritional or otherwise) that may influence the common cold 6. Currently taking part in another study that may compromise the results of this study 7. Currently pregnant, breast-feeding or planning to become pregnant during the study

Design outcomes

Primary

MeasureTime frame
URTI episode duration recorded using the Jackson common cold questionnaire completed daily by participants during the 3-month monitoring period

Secondary

MeasureTime frame
1. URTI parameters (number of episodes; severity ratings) recorded using the Jackson common cold questionnaire completed daily by participants during the 3-month monitoring period during their enrolment in the study 2. URTI episodes with swab-confirmed pathogen detection: participants will be instructed to collect a “self-swab” if they experience a URTI episode (self-reported via Jackson questionnaire). They will be required to take a throat swab (at the same time) on days 1, 3, 5 and 7 (where day 1 is the first day that symptoms are present). Samples will be screened for the presence of known URTI-causing pathogens using a commercially-available respiratory pathogen qPCR panel 3. Viral load in pathogen-confirmed URTI: relative viral load will be estimated using the Ct values derived from the qPCR panel, and an internal reference gene, for the pathogen screening mentioned above on days 1, 3, 5 and 7 (where day 1 is the first day that symptoms are present) 4. Training load and absence days (days missed training due to URTI): an exercise training log will be recorded prospectively by participants for all planned physical activity (exercise training) that they take part in. For every session, they will record session duration and overall rating of perceived exertion (RPE), which will be used to estimate the overall training load. If an URTI episode causes them to miss, or adjust their training vs what was planned, they will record this on their log. This will be used to calculate missed (or otherwise affected) training for the duration of the monitoring period (3 months).

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026