A prospective, placebo controlled, double-blind randomised cross over study evaluating the effects of xylitol-containing chewing gum versus ordinary chewing gum on recurrent purulent upper respiratory tract infections
| ISRCTN | ISRCTN15262355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15262355 |
| Protocol serial number | N0256119254 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 25/11/2019
- 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 of protocol
Not provided at time of registration
Contact information
Dr Peter Andrews
Scientific
Scientific
Department of ENT, RNTNE
Royal Free Hampstead NHS Trust
330 Grays Inn Road
Kings Cross
London
WC1X 8DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | A prospective, placebo controlled, double-blind randomised cross over study evaluating the effects of xylitol-containing chewing gum versus ordinary chewing gum on recurrent purulent upper respiratory tract infections |
| Study objectives | Does xylitol reduce the number of upper respiratory tract infections? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Upper respiratory tract infections |
| Intervention | Clinical trial |
| Intervention type | Other |
| Primary outcome measure(s) |
Service outcomes development. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients aged between 5-65. |
| Key exclusion criteria | Does not match inlcusion criteria |
| Date of first enrolment | 15/11/2002 |
| Date of final enrolment | 15/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Free Hampstead NHS Trust
London
WC1X 8DA
United Kingdom
WC1X 8DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/11/2019: No publications found. Verifying results with principal investigator.
30/11/2015: no publications found on PubMed.
