Dyspepsia | Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information.

Dyspepsia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Age 20 - 60 years - Rome II criteria fulfilled - Helicobacter test negative (urease-test) - Informed consent Exclusion Criteria: - Diabetes - Prior gastrointestinal surgery - Treatment with proton pump inhibitors / H2 blockers the last 30 days - Pregnancy / lactation - Current use of NSAIDs - Serious psychiatric illness - Serious egg allergy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?


Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Individualized and comprehensive informationThorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.

Drug:Lanzo Melt30mg, od, 1/2 h before meal

Drug:Lanzo Melt30mg, od, 1/2 h before meal

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group APatients is given thorough information based on the tests taken plus medical treatment.

Group BPatients receive simple written information based on the tests taken plus medical treatment.

Study Status

Unknown status

Start Date: January 2007

Completed Date: January 2015

Phase: N/A

Type: Interventional


Primary Outcome: Improvement of symptom score

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Valerij Glazkov, MD

Lead Sponsor: Helse Fonna


More information:

Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999 Sep;45 Suppl 2:II37-42. Review.

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