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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.


- candidate number2039
- NTR NumberNTR658
- ISRCTNISRCTN53060944
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR24-mrt-2006
- Secondary IDsN/A 
- Public TitleEvaluation of the mucosa-permeability of the stomach measured by the Ussing Chambers technique in patients with functional dyspepsia before and after treatment with amitriptyline.
- Scientific TitleEvaluation of the mucosa-permeability of the stomach measured by the Ussing Chambers technique in patients with functional dyspepsia before and after treatment with amitriptyline.
- ACRONYMSubstudy 2: permeability
- hypothesisThrough stress the mast cells become activated and by their vaso-active substances the mucosa permeability will become increased. Therefore the mucosa is easier to penetrated by microbes and acid. This increased permeability will leads to hypersensitivity, inflammation and pain.
- Healt Condition(s) or Problem(s) studiedFunctional dyspepsia (FD)
- Inclusion criteria1. Age 18-65 years;
2. Patients have to take part in the amitriptyline study;
3. Functional dyspepsia (NDI>25);
4. No depression (ZUNG<50);
5. No effect of PPI or 3 months constantly the same doses;
6. No medications which influence the intestine.
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2006
- Target number of participants60
- Interventions1. Patients: amitriptyline or placebo (see amitriptyline study);
2. Gastroscopy with biopsy.
- Primary outcomeTo show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryPatients who will take part to the amitriptyline study will get biopsy (6) during gastroscopy before the start of the amitriptyline study. 40 of the patients who join this substudy will get another gastroscopy with biopsy (6) at the end of the amitriptyline study. The biopsy will be analysed by using the Ussing chambers technique.
20 Healthy volunteers will get only one gastroscopy with biopsy (6).
- Main changes (audit trail)
- RECORD24-mrt-2006 - 18-nov-2008


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