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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20933

Enrollment

Registered

2006-03-24

Start date

2006-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia.

Interventions

1. Patients: amitriptyline or placebo (see amitriptyline study)

2. Gastroscopy with biopsy.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)