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
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