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

NCT00437346 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-12-16

No results posted yet for this study

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.

Conditions

  • Dyspepsia

Interventions

PROCEDURE

Individualized and comprehensive information

Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.

DRUG

Lanzo Melt

30mg, od, 1/2 h before meal

DRUG

Lanzo Melt

30mg, od, 1/2 h before meal

Sponsors & Collaborators

  • Helse Fonna

    lead OTHER

Principal Investigators

  • Valerij Glazkov, MD · Department of Medicine, Haugesund Hospital, N-5504 Haugesund, Norway

  • Jan G. Hatlebakk, MD, PhD · Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437346 on ClinicalTrials.gov