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
| ISRCTN | ISRCTN53060944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53060944 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands) |
| Funder | Academic Medical Center (AMC) |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 07/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G.E.E. Boeckxstaens
Scientific
Scientific
Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized controlled trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study objectives | 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 penetrate by microbes and acid. This increased permeability will lead to hypersensitivity, inflammation and pain. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Functional dyspepsia (FD) |
| Intervention | 1. Patients: amitriptyline or placebo (see amitriptyline study) 2. Gastroscopy with biopsy |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure(s) |
To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia. |
| Key secondary outcome measure(s) |
1. Is there a difference between healthy volunteers and patients with functional dyspepsia? |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Age 18-65 years 2. Patients have to take part in the amitriptyline study (ISRCTN76116512) 3. Functional dyspepsia (Nepean dyspepsia index [NDI] >25) 4. No depression (Zung self-rating depression scale <50) 5. No effect on proton pump inhibitor (PPI), or a constant three-month dosage of PPI 6. No medications which will influence the intestine |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
