Treating people with IBS: a randomised double-blind placebo controlled trial of IntestAidIB in people with Irritable Bowel Syndrome (IBS)
ISRCTN | ISRCTN67764449 |
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DOI | https://doi.org/10.1186/ISRCTN67764449 |
Secondary identifying numbers | N/A |
- Submission date
- 13/12/2005
- Registration date
- 15/12/2005
- Last edited
- 22/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christine Dancey
Scientific
Scientific
University of East London
School of Psychology
Romford Road
London
E15 4LZ
United Kingdom
Phone | +44 (0)208 223 4497 |
---|---|
C.P.Dancey@uel.ac.uk |
Study information
Study design | Randomised double-blind placebo-controlled cross-over study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | H1: treatment with a nucleotide supplement will significantly improve symptoms of irritable bowel syndrome when compared to placebo H2: psychological measures (depression; anxiety) will predict improvement in symptomatology H3: improvements in symptoms will be accompanied by improvements in psychological state, e.g. anxiety and depression |
Ethics approval(s) | Approved by the University of East London ethics committee. |
Health condition(s) or problem(s) studied | Irritable Bowel Syndrome (IBS) |
Intervention | Treatment by nucleotide supplements for 8 weeks and placebo for 8 weeks |
Intervention type | Other |
Primary outcome measure | Improvement in daily ratings of seven symptoms of IBS (self report) above placebo level. |
Secondary outcome measures | Improvement in anxiety and depression ratings (self report) following experimental condition. |
Overall study start date | 01/10/2004 |
Completion date | 30/09/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Key inclusion criteria | Participants should be aged 1865, should have been diagnosed as having IBS by a qualified medical practitioner, and should have diarrhoea as a main symptom. |
Key exclusion criteria | Any other co-existing illnesses, and non-confirmation of the diagnosis by GP. |
Date of first enrolment | 01/10/2004 |
Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of East London
London
E15 4LZ
United Kingdom
E15 4LZ
United Kingdom
Sponsor information
University of East London (UK)
University/education
University/education
School of Psychology
Romford Road
London
E15 4LZ
England
United Kingdom
Phone | +44 (0)208 223 4461 |
---|---|
E.A.Attree@uel.ac.uk | |
https://ror.org/057jrqr44 |
Funders
Funder type
Industry
Wyreside Products Limited
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 | 08/06/2006 | Yes | No |