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
Secondary identifying numbers	N/A

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

Dr G.E.E. Boeckxstaens
Scientific

Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

Study design	Non-randomized controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure	To show that the permeability of the mucosa in stomach and duodenum is increased in (stress-sensitive) patients with functional dyspepsia.
Secondary outcome measures	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
Overall study start date	01/05/2006
Completion date	01/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	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

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

University/education

Academic Medical Center (AMC)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan