Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively 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 G E E Boeckxstaens

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR40

Study information

Scientific title

Budesonide as treatment for patients with irritable bowel syndrome

Acronym

Study hypothesis

To evaluate budesonide as treatment for patients with irritable bowel syndrome.

Ethics approval

Ethics approval received from the local ethics committee.

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Budesonide

Primary outcome measures

The effect of budesonide on the rectal sensitivity in IBS.

Secondary outcome measures

1. The effect of budesonide on inflammation in rectal biopsy specimen
2. The effect of budesonide on IBS-symptoms

Overall trial start date

01/04/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Severe comorbidity
2. Pregnancy/lactation

Recruitment start date

01/04/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

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

Publication citations

Additional files

Editorial Notes