(stress-sensitive) Patients with functional dyspepsia have a change in the dopaminergic system, through chronic stress, what leads to visceral hypersensitivity and therefore dyspeptic symptoms.
Bron
Verkorte titel
Aandoening
Functional Dyspepsia (FD)
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
To evaluate if patients with functional dyspepsia have a change in their dopaminergic system what leads to visceral hypersensitivity.
Achtergrond van het onderzoek
40 Patients who will join the amitriptyline study can also take part to this substudy. Patients will undergo the SPECT imaging and AMPT challenge test before and at the end of the treatment with amitriptyline/placebo.
20 healthy Volunteers will get the investigations only once. With their help we want to get normal values from the dopaminergic system.
Doel van het onderzoek
(stress-sensitive) Patients with functional dyspepsia have a change in the dopaminergic system, through chronic stress, what leads to visceral hypersensitivity and therefore dyspeptic symptoms.
Onderzoeksproduct en/of interventie
1. Amitriptyline or placebo for the patient group (see the amitriptyline study);
2. Single Photon Emission Computed Tomography (SPECT) imaging with [123I] IBZM radioligand;
3. Alpha-methyl-paratyrosine (AMPT, =metyrosine) challenge test. 2x 500 mg.
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. Functional dyspepsia (NDI>25);
3. Take part in the amitriptyline study;
4. No effect of PPI or 3 months constantly the same doses;
5. No depression (ZUNG<50);
6. No medications which influence the intestine.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Gastroduodenal surgery;
2. Reflux-like dyspepsia (Rome II criteria);
3. Use of antidepressivants;
4. Organic abnormalities;
5. Pregnancy;
6. Severe cardiac, renal, pulmonary, hepatic or systemic diseases. Hyperthyroidism, glaucoma and epilepsy;
7. Metal implantates.
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 | NL601 |
NTR-old | NTR657 |
Ander register | : N/A |
ISRCTN | ISRCTN63226989 |