No registrations found.
ID
Source
Brief title
Health condition
Functional dyspepsia.
Sponsors and support
Intervention
Outcome measures
Primary outcome
To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
Secondary outcome
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.
Background summary
Patients 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).
Study objective
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 penetrated by microbes and acid. This increased permeability will leads to hypersensitivity, inflammation and pain.
Study design
N/A
Intervention
1. Patients: amitriptyline or placebo (see amitriptyline study);
2. Gastroscopy with biopsy.
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Inclusion criteria
1. 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL602 |
| NTR-old | NTR658 |
| Other | : N/A |
| ISRCTN | ISRCTN53060944 |