Condition category
Digestive System
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/09/2011
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

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

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes