Evaluation of the mucosa-permeability of the stomach measured by the Ussing Chambers technique in patients with functional dyspepsia before and after treatment with amitriptyline

ISRCTN ISRCTN53060944
DOI https://doi.org/10.1186/ISRCTN53060944
Secondary identifying numbers N/A
Submission date
07/06/2006
Registration date
07/06/2006
Last edited
07/09/2011
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

Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5667375
Email g.e.boeckxstaens@amc.uva.nl

Study information

Study designNon-randomized controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThrough 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFunctional dyspepsia (FD)
Intervention1. Patients: amitriptyline or placebo (see amitriptyline study)
2. Gastroscopy with biopsy
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amitriptyline
Primary outcome measureTo show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
Secondary outcome measures1. 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 study start date01/05/2006
Completion date01/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2006
Date of final enrolment01/05/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

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

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Center (AMC)
Private sector organisation / Universities (academic only)
Alternative name(s)
Academic Medical Center, AMC
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan