Contact information
Type
Scientific
Primary contact
Dr G.E.E. Boeckxstaens
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Through stress, the mast cells become activated, and by their vaso-active substances the mucosa permeability will become increased. Therefore the mucosa is easier to penetrate by microbes and acid. This increased permeability will lead to hypersensitivity, inflammation and pain.
Ethics approval
Not provided at time of registration
Study design
Non-randomized controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Functional dyspepsia (FD)
Intervention
1. Patients: amitriptyline or placebo (see amitriptyline study)
2. Gastroscopy with biopsy
Intervention type
Drug
Phase
Not Specified
Drug names
Amitriptyline
Primary outcome measures
To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
Secondary outcome measures
1. Is there a difference between healthy volunteers and patients with functional dyspepsia?
2. Amitriptyline has a positive effect on the mucosa permeability by reducing the level of stress and the dyspeptic symptoms will be improved
Overall trial start date
01/05/2006
Overall trial end date
01/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18-65 years
2. Patients have to take part in the amitriptyline study (ISRCTN76116512)
3. Functional dyspepsia (Nepean dyspepsia index [NDI] >25)
4. No depression (Zung self-rating depression scale <50)
5. No effect on proton pump inhibitor (PPI), or a constant three-month dosage of PPI
6. No medications which will influence the intestine
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Gastroduodenal surgery in history
2. Reflux-like dyspepsia (Rome II criteria)
3. Use of antidepressants
4. Organic abnormalities
5. Severe cardiac, renal, pulmonary, hepatic, or systemic diseases, hyperthyroidism, glaucoma and epilepsy
Recruitment start date
01/05/2006
Recruitment end date
01/05/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
University/education
Funder name
Academic Medical Center (AMC)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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