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…
ID
Bron
Verkorte titel
Aandoening
Functional dyspepsia.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. Patients: amitriptyline or placebo (see amitriptyline study);
2. Gastroscopy with biopsy.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL602 |
| NTR-old | NTR658 |
| Ander register | : N/A |
| ISRCTN | ISRCTN53060944 |