Irritable Bowel Syndrome: Budesonide
| ISRCTN | ISRCTN31751611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31751611 |
| Protocol serial number | NTR40 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 10/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 G E E Boeckxstaens
Scientific
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Budesonide as treatment for patients with irritable bowel syndrome |
| Study objectives | To evaluate budesonide as treatment for patients with irritable bowel syndrome. |
| Ethics approval(s) | Ethics approval received from the local ethics committee. |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome (IBS) |
| Intervention | 3 mg budesonide three times a day (TID) or placebo for two months. Patients will undergo a barostat before and after treatment. Prior to the barostats six rectal biopsies will be taken via a proctoscope. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Budesonide |
| Primary outcome measure(s) |
The effect of budesonide on the rectal sensitivity in IBS. |
| Key secondary outcome measure(s) |
1. The effect of budesonide on inflammation in rectal biopsy specimen |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Key inclusion criteria | 1. Fulfilling Rome II criteria of Irritable Bowel Syndrome (IBS) 2. 18 to 65 years of age 3. No other organic abnormalities explaining the complaints |
| Key exclusion criteria | 1. Severe comorbidity 2. Pregnancy/lactation |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
