Clinical Trial: Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information.

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility.

Brief Summary:

Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information.

Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. The most important relevant medical examination is gastroscopy, and if the findings are normal the condition is usually classified as functional dyspepsia.

Several disturbances of function are now known as potential causes of such symptoms, and the optimal choice of treatment may vary.

In the study the investigators plan to examine whether different types of functional disturbances respond differently to medical therapy. In particular, the investigators want to assess whether comprehensive and individualized information will influence the results of therapy. This has not been previously studied systematically.

The investigators also postulate that disturbances of function of the esophagus may cause complaints that should be classified as functional dyspepsia even if the symptoms are atypical. Few studies have been done to evaluate this hypothesis, and there may be potential consequences for choice of appropriate treatment.

In animal models and in humans is recently demonstrated that elevated gastric pH because of anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study and eventually development of food allergy will influence patient's condition in an observations period. That why we're observing IgE dynamics in our study.


Detailed Summary:

Purpose

Functional dyspepsia is a common disorder affecting approximately 25 % of the adult population. Functional dyspepsia is defined from symptoms according to the Rome II criteria. A normal upper endoscopy is also warranted Many of these patients have specific motility disorders. A more accurate diagnosis could mean a more effective treatment.

In this study the patients take several tests in order to make a more specific diagnosis. These include: 24 hour pH-monitoring, oesophagusmanometry, drink test and scintigrafy.

We will study the effect of acid reducing treatment (proton pump inhibitors) on the different dysmotility-types and also the effect of medical information and advise.

We will observe concentrations of total IgE and various specific antibodies against food allergens in serum when taking PPI. Results here can vary dependent on whether the patient has used PPI anytime before or not.

Patients

The patients are included via referrals from general practitioners and hospital doctors. An upper endoscopy is performed. If this investigation is normal the patient is considered for inclusion in the study.

Criteria for inclusion are

  • Age 20 - 60 years
  • Rome II criteria fulfilled
  • Helicobacter test negative (urease-test)
  • Informed consent

Criteria for exclusion are