Proposal for Research in Helicobacter pylori and its Relationship with Dyspepsia

Robert Garcia
March 6, 2014
California State University Fullerton
800N.State College Blvd.
Fullerton, CA 92831
Phone: 657-278-2011
E-mail: R.garcia93@live.com









Abstract
The goal of this research is to gain an understanding of the relationship between H. Pylori
and dyspepsia. A second goal is to find out if the Test for H. Pylori and treat (Chiba et al.,
2002) strategy improves symptoms of dyspepsia and if there is an economic benefit to the
strategy. The location of the study will be done at family practices. The hypothesis is that the
Test for H. Pylori and treat strategy will improve symptoms of dyspepsia and will be
economically beneficial to patients. The proposed research will be a double blind placebo study
involving patients who show symptoms of dyspepsia, the participants will be randomly drawn
and examined at monthly intervals in a twelve month period. The examinations will evaluate
symptoms and their degree of pain, and participants will be given a questionnaire to determine
their annual spending based on their dyspepsia symptoms.
Searchable key words: Helicobacter pylori; Double blind study; Placebo; Dyspepsia;
Gastrointestinal ; C-urea breath test
Project Description:
Objectives
The objective of the proposed research is to gain a new understanding of the relationship
between Helicobacter pylori and dyspepsia. The proposed research will question if treating H.
pylori will improve symptoms of dyspepsia, as well as improving patients life. A second
objective of the proposed research is to find out if the treatment strategy of test for H. pylori and
treat strategy is economically beneficial to patients who suffer from dyspepsia. The objectives
of the research are in line with the NSFs goals of progressing science and national health. The
study will progress science and national health by discussing the relationship between H. pylori
and dyspepsia. Discussion could lead to the improvement of the quality of life of individuals who
suffer from dyspepsia. The proposed research is also in line with the goal of advancing
prosperity by examining the economical benefits of using a test for H. pylori and treat strategy
to cure dyspepsia symptoms. The use of the treatment strategy will save patients as well as
hospitals money. Patients will save money by not having to endure test that are more invasive
and cost more money. Hospitals will save money by not having to pay for the more expensive
and invasive test.
The significance of the proposed research is that up to 40 percent of the population
suffers from dyspepsia symptoms which decrease their quality of life (Chiba et al., 1998). The
numerous people claiming upper gastrointestinal symptoms are often uninvestigated and the
reasoning for their symptoms are usually unknown (Chiba et al., 2002). The proposed research
will find out if testing routinely for H. pylori improves dyspepsia symptoms. Improving
dyspepsia symptoms with the test for H. pylori and treat strategy may also prove economically
beneficial. The strategy is just a C- urea breath test while other tests are invasive and expensive
and may include more frequent doctor visit to find the cause of the dyspepsia. If the proposed
research is accepted it will improve the quality of life for a large percentage of the population
who suffer from dyspepsia. It may also provide evidence that the test for H. pylori and treat
strategy is economically beneficial to patients and to the medical field.
Relation to the present state of knowledge in the field
The present stage of knowledge of the relationship between H. pylori and gastrointestinal
ailments are that it is linked to cause duodenal ulcers and gastric ulcers and gastric cancer
(Huang, et al., 1998) and MAlToma (Bayerdrffer et al., 1995). The relationship between
dyspepsia and H. pylori though has been in controversy because positive and negative trials had
been reported (Moayyedi, et al., 2000) (Laine, et al., 2001). The proposed study will help in
determining if curing H, pylori has a beneficial impact on reducing symptoms of dyspepsia, and
will hopefully lead to more research on the subject.
General plan of work:
The proposed research will be a double blind placebo study that involves participants
who suffer from dyspepsia symptoms. The double blind placebo study will have a control group
that will be using placebos and an experimental group who will take the appropriate medicines.
The experimental group will also be using the test for H. pylori and treat strategy. The control
will be using placebos to serve as a comparison to the experimental group. With a control the
effects of the medicine can be examined because the only difference is that the experimental will
be using medicines to cure H. pylori and any differing symptom improvements will be the result
of curing H. pylori. The participants will be over 18 and show uninvestigated symptoms of
dyspepsia within three months. Dyspepsia symptoms will be defined as discomfort in the upper
gastrointestinal tract, and with symptoms of heartburn, acid regurgitation, and excessive burping
and belching. Participants will be excluded if their symptoms indicate that they have gastro-
oesophageal disease. Participants who had gastrointestinal endoscopy or barium study within six
months of the beginning of the study, gastric surgery, documented ulcer disease or laboratory
abnormalities will also excluded from the study. Excluding patients will insure that the
symptoms where caused by dyspepsia and no other gastrointestinal illness. The participants will
do a C-urea breath test before the study to insure that their bodies contain H. pylori. The
participants will then be randomized into a control and experimental group using a computer.
The participants will be given medication in sealed envelopes containing the specific drug. The
drugs will be either omeprazole 20mg, metronidazole 500mg and clarithromycin250mg or a
placebo that looks like the same drugs. The information about which patient got the placebo or
the real medication will not be known until the end of the study, to ensure no bias in recording
the results. The patients will receive the drugs twice daily for seven days and would be followed
up in 12 months. The participants will be monthly assessed by their family practioners. During
the assessments the patients will be given questionnaires to rate their dyspepsia symptoms as
well as a quality of life questionnaire. The questionnaires will be rated on a seven point scale
from 1 no problems to 7 of very severe problems. In addition to the questionnaires the
participants will also be given a C-urea breath test every three months. These questionnaires are
given to find out if the symptoms of dyspepsia where improving over the 12 month interval and
the breath test would show if it was a result of the depleting H. pylori. Participants would also
be given a dyspepsia related health utilization health cost questionnaire every month that would
show the annual cost of individuals who used the test for H. pylori and treat strategy and those
who were on the placebo. If our prediction is correct and the test for H. pylori and treat strategy
is economically beneficial then the cost would be less than the placebo group. The cost would be
less because they would spend less time going to the doctors and doing more test because their
symptoms would all ready being treated. The benefits of a successful study will show that testing
and treating H. pylori will result in diminished dyspepsia symptoms that improve patients
quality of life as well as economical benefits of not needing to pay for frequent doctor visits
because of constant symptoms.
Broader impacts:
The broader impacts of the proposed research are that it advances the well-being of
individuals in society. If the proposed research is correct then treating H. pylori will results in
diminished symptoms of dyspepsia. This will improve the quality of life of individuals who
suffer from dyspepsia. It also will prove to be economically beneficial because individuals who
are treated for the eradication of H. pylori will save money because they will not have frequent
doctor visits and have invasive test. These will prove beneficial to a large majority of the
population because as stated before up to 40% of the population suffer from dyspepsia. A vast of
majority of people will see improvements in their well being both physically and financially.
References Cited:
Bayerdrffer F, Neubauer A, Rudolph B, Thiede C , Lehn N, Eidt S, et al. Regression of primary
gastric lymphoma of mucosa-associated lymphoid tissue type after cure of Helicobacter
pylori infection[see comments].Lancet 1995;345:1591-4.
Chiba N. et. al. 2002. Treating Helicobacter pylori infection in primary care patients with
uninvestigated dyspepsia . . . . British Medical Journal. WIS 251.
Chiba N, Bernard L, OBrian BJ, Georee R, Hunt RH. A Canadian physician survey of dyspepsia
management. Can J Gastroenteral 1998; 12: 83.-90.
Huang JQ, Sridhar, Chen Y, Hunt RH. Meta-analysis of the relationship between Helicobacter
pylori seropostivity and gastric cancer. Gastroenterology1998;114:1169-79.
Laine L, Schoenfeld P,Fennerty MB. Therapy for Helicobacter pylori in patients with no ulcer
dyspepsia. A meta-analysis of randomized , controlled trials. Ann Intern Med
2001;134:361-9.
Moayyedi P, Soo S, Deeks J, Forman D, Mason J, Innes M, et al. Systematic review and
economic evaluation of Helicobacter pylori eradication treatment for non-ulcer
dyspepsia. BMJ 2000;321:659-64.
Biographical Sketch
My educational background is that I am a junior at California State University Fullerton.
I am biology major who is interested in having a concentration in microbiology. The relevant
courses that I have taken are Bio 101 Introduction to Biology and Bio 171Evoultion and
Biodiversity. These two classes have given me knowledge about different microorganisms and
their ability to help or harm their body. They have also taught me how to create and prepare real
world experiments. I have not been part of any independent research projects but a plan on doing
some in the future. I do not have any related work experience with either H. pylori or dyspepsia.
My current academic status is that I am a junior in college who plans to graduate in the spring of
2016.







Homework
Points-to-make list
Abstract:
Goals of dong this research: To gain an understanding of the relationship between H. Pylori and
dyspepsia. Determine if the Test for H. pylori and treat: strategy improves symptoms for
patients who suffer from dyspepsia. To find if there is an economic benefit to doing the strategy.
Location of study: At Family practices in Canada
Hypothesis of the study: Test for H. pylori and treat strategy will improve symptoms of
dyspepsia and will be economically help to patients
How the study: will be done by doing a double blind study involving 294 patients who show
symptoms of dyspepsia, The participants will be randomly drawn and will be examined at
different interval in a twelve month period.
Project Description:
Objectives of proposed work: To gain a understanding of the relationship between Helicobacter
pylori and dyspepsia.
Significance of work: Will innovate a more effective treatment option that will improve
symptoms and be cost effective.
Present stage of knowledge of Subject in field of work: Positive and negative results of the
relationship between H. pylori and dyspepsia
Long term goals: Will create a new way of thinking of the relationship between H .Pylori and
dyspepsia that had not been searched before.
Outline of general plan of work: We will gather 294 participants in Canada who show
symptoms of dyspepsia. Put them in a double blind placebo study. The patience will be evaluated
monthly and will be subject to Quality of life questionnaire, gastrointestinal symptoms rating
scale questionnaire, and a dyspepsia related health utilization costs questionnaire .These
questionnaire were used to evaluate if symptoms improved and the cost benefits of doing the
test for H. pylori and treat strategy.
Broader impacts: Will give new research on a subject that will help many people who suffer
from dyspepsia
Cluster 1:
Objectives of proposed work: To gain an understanding of the relationship between
Helicobacter pylori and dyspepsia.
Significance of work: Will innovate a more effective treatment option that will improve
symptoms and be cost effective.
Cluster 2:
Present stage of knowledge of Subject in field of work: Positive and negative results of
the relationship between H. pylori and dyspepsia
Long term goals: Will create a new way of thinking of the relationship between H .Pylori
and dyspepsia that had not been searched before.
Broader impacts: Will give new research on a subject that will help many people who
suffer from dyspepsia

Cluster 3:
Outline of general plan of work: We will gather participants who show symptoms of
dyspepsia. Put them in a double blind placebo study. The patience will be evaluated monthly and
will be subject to Quality of life questionnaire, gastrointestinal symptoms rating scale
questionnaire, and a dyspepsia related health utilization costs questionnaire These questionnaire
were used to evaluate if symptoms improved and the cost benefits of doing the test for H. pylori
and treat strategy.