Randomised double blind placebo controlled internet trial of probiotics and ankylosing spondylitis (PAS- trial)
| ISRCTN | ISRCTN36133252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36133252 |
| Protocol serial number | 04/2/018 |
| Sponsor | University of Wales, Swansea (UK) |
| Funder | National Ankylosing Spondylitis Society (NASS) |
- Submission date
- 28/05/2004
- Registration date
- 07/07/2004
- Last edited
- 28/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Allen
Scientific
Scientific
Clinical School
University of Wales, Swansea
Singleton Park
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 513483 |
|---|---|
| s.j.allen@swansea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PAS trial |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration, information added 28/01/08: ethical approval granted by London MREC ref 04/2/18 in 2004. |
| Health condition(s) or problem(s) studied | Ankylosing spondylitis |
| Intervention | Probiotic versus placebo Participants are recruited through the internet (confirmation of diagnosis by general practitioner/rheumatologist) and assessed by weekly internet questionnaires. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotics |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 140 |
| Key inclusion criteria | Patients with a diagnosis of ankylosing spondylitis or other spondyloarthropathy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Clinical School
Swansea
SA2 8PP
United Kingdom
SA2 8PP
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? |
|---|---|---|---|---|---|
| Results article | results | 11/01/2008 | Yes | No |
