Condition category
Musculoskeletal Diseases
Date applied
28/05/2004
Date assigned
07/07/2004
Last edited
28/01/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Allen

ORCID ID

Contact details

Clinical School
University of Wales
Swansea
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 513483
s.j.allen@swansea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/2/018

Study information

Scientific title

Acronym

PAS trial

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration, information added 28/01/08: ethical approval granted by London MREC ref 04/2/18 in 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Probiotics

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a diagnosis of ankylosing spondylitis or other spondyloarthropathy

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

140

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical School
Swansea
SA2 8PP
United Kingdom

Sponsor information

Organisation

University of Wales, Swansea (UK)

Sponsor details

Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 602058
s.j.allen@swansea.ac.uk

Sponsor type

University/education

Website

http://www.swansea.ac.uk

Funders

Funder type

Charity

Funder name

National Ankylosing Spondylitis Society (NASS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18190710

Publication citations

  1. Results

    Brophy S, Burrows CL, Brooks C, Gravenor MB, Siebert S, Allen SJ, Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy., BMC Musculoskelet Disord, 2008, 9, 4, doi: 10.1186/1471-2474-9-4.

Additional files

Editorial Notes