Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437346
Status:
TERMINATED
Last Update Posted:
2019-12-16
First Post:
2007-02-15
Brief Title:
Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information
Sponsor:
Helse Fonna
Organization:
Helse Fonna
Study Overview
Official Title:
Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The project leader left our hospital and the project were shut down
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients condition in an observations period That why were observing IgE dynamics in our study
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 patients condition in an observations period That why were observing IgE dynamics in our study
Detailed Description:
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
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
Study design
Start of the study symptom score based on symptoms within the last three days Lanzo melt 30 mg daily is given as a morning dose Patients are randomized in two groups Group A is given thorough information based on the tests taken plus medical treatment Group B receives medical treatment only
After two weeks symptom score per telephone After four weeks a new symptom score A reduction by at least 25 is defined as treatment response These patients continue their medical treatment for three months Now all patients receive thorough information
Non responders end their medical treatment and they are followed with medical information and advise the next three months
After eight weeks symptom score per telephone After 12 weeks symptom score per telephone After 16 weeks the study is ended Symptom score is taken
After 4 and 16 weeks the patient evaluates hisher treatment in five categories Very satisfied satisfied less satisfied no change worse
Symptom score
Seven symptoms are scored from 1-7 points based on the last week The symptoms are regurgitation nausea early satiety belching pain referred to meals pain not referred to meals postprandial fullness
1 No symptoms
2 Insignificant symptoms as usual ignored
3 Light symptoms easy to ignore
4 Moderate symptoms easy to tolerate
5 Quite marked symptoms not easy to tolerate
6 Marked symptoms affects daily activities
7 Substantional symptoms cant do daily activities
24 hour pH monitoring
Digitrapper III from Synectics is used A probe is installed trans nasally to the gastric lumen where a pH value is registered Afterwards the probe is placed five cm over the upper border of the lower esophageal sphincter LES After 24 hours registration is completed and analyzed with the use of Polygram 98 from Medtronic Functional Diagnostics AS
Total reflux index reflux with meals postprandial reflux nightly reflux and long reflux episodes are registered Pathologic reflux index is defined as pathological if reflux is over 5
Acid Clearence Time ACT is also estimated It is found by dividing total reflux time with the number of refluxes Upper normal limit is set to 085 minutesreflux
Esophagusmanometry
We use perfusion manometry The catheter has sensors in five levels five cm apart LES is first localized and length and resting pressure are registered We test for normal relaxation with swallowing Then we test the motility peristalsis and amplitudeduration of pressure waves
Scintigraphy
We give a standard meal composed of two omelets one slice of bread and a glass of water Radioactive Technesium is injected into the omelet and the meal is eaten in ten minutes Picture uptakes are taken according to the protocol the first hour after completion of the meal Gastric emptying time is estimated
Drink test The patients drink water 150 mlmin until they feel they must stop Symptoms are registered when they stop and 15 and 30 minutes there after This is a test to determine accommodation and visceral sensibility
Blood tests Hemoglobin sedimentation rate CRP leucocytes thrombocytes bilirubin ALP ALAT g-GT albumin and amylase are taken to exclude organic disease It does not represent a variable in the study design
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
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
Study design
Start of the study symptom score based on symptoms within the last three days Lanzo melt 30 mg daily is given as a morning dose Patients are randomized in two groups Group A is given thorough information based on the tests taken plus medical treatment Group B receives medical treatment only
After two weeks symptom score per telephone After four weeks a new symptom score A reduction by at least 25 is defined as treatment response These patients continue their medical treatment for three months Now all patients receive thorough information
Non responders end their medical treatment and they are followed with medical information and advise the next three months
After eight weeks symptom score per telephone After 12 weeks symptom score per telephone After 16 weeks the study is ended Symptom score is taken
After 4 and 16 weeks the patient evaluates hisher treatment in five categories Very satisfied satisfied less satisfied no change worse
Symptom score
Seven symptoms are scored from 1-7 points based on the last week The symptoms are regurgitation nausea early satiety belching pain referred to meals pain not referred to meals postprandial fullness
1 No symptoms
2 Insignificant symptoms as usual ignored
3 Light symptoms easy to ignore
4 Moderate symptoms easy to tolerate
5 Quite marked symptoms not easy to tolerate
6 Marked symptoms affects daily activities
7 Substantional symptoms cant do daily activities
24 hour pH monitoring
Digitrapper III from Synectics is used A probe is installed trans nasally to the gastric lumen where a pH value is registered Afterwards the probe is placed five cm over the upper border of the lower esophageal sphincter LES After 24 hours registration is completed and analyzed with the use of Polygram 98 from Medtronic Functional Diagnostics AS
Total reflux index reflux with meals postprandial reflux nightly reflux and long reflux episodes are registered Pathologic reflux index is defined as pathological if reflux is over 5
Acid Clearence Time ACT is also estimated It is found by dividing total reflux time with the number of refluxes Upper normal limit is set to 085 minutesreflux
Esophagusmanometry
We use perfusion manometry The catheter has sensors in five levels five cm apart LES is first localized and length and resting pressure are registered We test for normal relaxation with swallowing Then we test the motility peristalsis and amplitudeduration of pressure waves
Scintigraphy
We give a standard meal composed of two omelets one slice of bread and a glass of water Radioactive Technesium is injected into the omelet and the meal is eaten in ten minutes Picture uptakes are taken according to the protocol the first hour after completion of the meal Gastric emptying time is estimated
Drink test The patients drink water 150 mlmin until they feel they must stop Symptoms are registered when they stop and 15 and 30 minutes there after This is a test to determine accommodation and visceral sensibility
Blood tests Hemoglobin sedimentation rate CRP leucocytes thrombocytes bilirubin ALP ALAT g-GT albumin and amylase are taken to exclude organic disease It does not represent a variable in the study design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None