Studying the Effects of Treatment of Helicobacter pylori Infection on

Recurrence of Gastric or Duodenal Ulcer

March 17, 2014

Rebecca Vargas, revargas@yahoo.com, (714) 328-5374
David Y. Graham, dgraham@yahoo.com , (714) 968-2152
Ginger M. Lew, glew@yahoo.com , (714) 785-6311
Peter D. Klein, pklein@yahoo.com , (714) 985-6335
Dolores G. Evans, devans@yahoo.com , (714) 123-4568
Doyle J. Evans, djevans@yahoo.com , (714) 987-6932
Zahid A. Saeed, zsaeed@yahoo.com , (714) 874-5465
Hoda M. Malaty. hmalaty@yahoo.com , (714) 547-8563
1100 Bates Street, Houston, TX 77030
































Abstract:
Peptic ulcer disease is a painful disease which may appear frequently throughout a
persons lifetime. Previous studies have shown that Helicobacter pylori (H. pylori)
infection impacts the recurrence of ulcer disease. We propose to determine the effect of
treating H. pylori infection on recurrence of gastric and duodenal ulcer disease. The main
research objective is to define the effectiveness of histamine blockers ranitidine and
ranitidine plus triple therapy in a follow-up study of previously healed ulcer patients.
Patients will be treated with either ranitidine or triple therapy in order to compare the
effects on H. pylori infection. The efficiency of these treatments will then be evaluated in
order to specify the recurrence rate of duodenal and gastric ulcer disease. We hope to see
a substantial ulcer disease recurrence rate decrease in recurrence rate of ulcer disease in
patients treated with this triple therapy.

Keywords: Peptic Ulcer Disease, Helicobacter pylori, ranitidine, triple therapy, ulcer
disease treatment

Proposal
I ntroduction:
Peptic ulcer disease is defined as having painful sores in the lining of the stomach
or the duodenum, which is the first part of the small intestine. Ulcers may appear due to
imbalances between digestive fluids and the stomach/duodenum. A few reasons for Tthe
appearance of ulcers can be caused by an infection with Helicobacter pylori (H. pylori)
or excess use of painkillers. Ulcers can cause serious health problems such as
perforations through the wall of the stomach or gastric obstruction. Treatments for peptic
ulcers caused by an infection with H. pylori include antibiotics or making personal
changes in onesa persons daily routine such as their eating habits [1].
Even though the recurrence of ulcers is reduced with the consistent treatment of
antiulcer therapy, it does not affect the natural history of the disease because recurrence
resumes rapidly once therapy is stopped. [2] Recent research has suggested that by
diminishing H. pylori infections, the rate of recurrence decreases significantly [3-7].
However, these studies did not use control groups making so this made it difficult to
properly interpret results [4, 6,7]. Studies on the elimination of H. pylori on patients with
peptic ulcers have not been conducted yet. Studies relating to the elimination of H. pylori
will have a long term effect on patients which would potentially better their way of life.
We plan to conduct trials with appropriate controls to determine the effects of a
novel therapy designed to eliminate H. pylori and reduce the occurrence of ulcers in
patients with duodenal/gastric ulcer disease. Our main research objective is to define the
effect of treating H. pylori infection on the reoccurrence of ulcer disease in a two year
follow up.
Proposed Methodology:
Our 146 participants for this study will be patients who have been healed from
gastric ulcers from a previous study where patients were randomly assigned to consume
histamine blockers. Our study will take place at a Veterans Affairs hospital for a total of
two years. We have designed a novel method that will involve treating patients with
ranitidine plus triple therapy and ranitidine. Ranitidine is a histamine blocker that inhibits
stomach acid production. It is commonly used to treat peptic ulcer disease. By using both
of these substances we will be able to compare both methods of therapy to each other.
Comment [C1]: Reword

We hypothesize that ranitidine triple therapy will have significantly lasting effects on
participants due to the antimicrobial agents that are involved in ranitidine plus therapy.
These agents have been aimed to target H. pylori bacteria. Patients will receive 300 mg of
ranitidine or ranitidine plus therapy which is composed of tetracycline, metronidazole,
and bismuth subsalicylate. Ranitidine plus therapy will be administered for the first two
weeks of treatment. Ranitidine therapy will be continued until the ulcer has healed. Once
healed, no additional therapy will be given. Patients will be required to return for an
endoscopy to assess ulcer recurrence every three months for a maximum of two years.
This endoscopy will allow progress of the treated ulcer to be recorded over time. In order
to ensure data validity, the endoscopist will be blinded to the treatment status of the
patient. A C-urea breath test will be used to assess patients for the H. pylori infection.
Ulcer recurrence will be statistically analyzed by using the life-table method through
SAS/STAT software. All P-values< 0.005 will be considered significant.
Broader Impacts:
We anticipate to see a decrease in ulcer recurrence in patients who have been
treated with ranitidine triple therapy. By reducing the recurrence of peptic ulcers, people
suffering from this disease will have be provided with a better way of life. This new
proposed method may lead to new treatment for ulcer disease and will provide new
knowledge about future treatments involving ulcer disease and about the disease itself.
Our main goal is to provide further improvement of lifestyle for those suffering from
ulcer disease.
Biographical Sketch:
Comment [C2]: Build this section
Rebecca Vargas is an undergraduate at California State University, Fullerton. Her
major is biochemistry. She has taken all the core courses in biology and chemistry in the
chemistry/biochemistry department. Her research interests in the past were based on
identifying an additional copper transporter on cells that do not show expression of the
only known copper transporter (CTR1). She is interested in biochemistry and drug
discovery. Her current interests are conducting research on the treatment of peptic ulcers
to better the lifestyle of people who have peptic ulcer disease. She intends on pursuing a
graduate degree in this field. Her expected graduation date is May 2015.
























References:
[1] Digestive Disorders Health Center. WebMD Answers.
[2] Sontag SJ. Current status of maintenance therapy in peptic ulcer disease. Am J
Gastroenterol. 1988; 83: 607-17
[3] Coghlan JG, Gilligan D, Humphries H, McKenna D, Dooley C, Sweeney E, et al.
Campylobacter pylori and Recurrence of Duodenal Ulcers: A 12-Month Follow-
Up Study. Lancet. 1987.
[4] Lambert JR, Borromeo M, Korman MG, Hansky J, Eaves ER. Effect of Colloidal
Bismut on Healing and Relapse of Duodenal Ulcers-role of Campylobacter
pyloridis. Gastroenterology. 1987.
[5] Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, et
al. Propective Double-blind trail of Duodenal Ulcer Relapse after Eradication of
Campylobacter pylori. Lancet. 1988.
[6] Rauws EA, Tytgat GN. Cure of Duodenal Ulcer Associated with Eradication of
Helicobacter pylori. Lancer. 1990.
[7] George LL, Borody TJ, Andrews P, Devine M, Moore-Jones D, Walton M. et al.
Cure of Duodenal Ulcer after Eradication of Helicobacter pylori. Med J. 1990.













Storyboard Method:
I really enjoyed trying out this new method. I started out by just writing what came to my
head. I thought about additional details that I would want to know underneath of the main
topics. I was then able to put them together in an order that I thought was good.











Proposal Grading Rubric
1


The following rubric reflects this assignments priorities the highest priority is content, the lowest
priority is mechanics. A check mark in a given box indicates how well the document addresses the
criteria listed in each category.

Category Excellent Good Fair
Content:
Provides all information
required by the RFP;
Offers a clear description
of the project and supports
ideas and assertions;
Makes a persuasive case for
why the project deserves
funding.




X

Organization:
Uses format prescribed by
RFP;
Progresses logically and
gives transition to ideas;
Presents related ideas
coherently.



X

Audience:
Writes to a clearly defined
audience;
Understands the readers
needs as found in the RFP;
Considers the readers
obligations.



X

Style:
Reflects an awareness of
style choices (rhythm,
sentence structure, voice,
development).


X

Mechanics:
Gives full attention to
grammar and to proper
presentation.

X

Comments:
Three aspects of the proposal that work well:
1. The proposal is well organized.
2. The proposals content is clear and well defined.
3. The proposal has great style and flow.

Three aspects of the proposal that call for revision:
1. There are several prepositions that need revision.
2. Some sentences need to be restructured.
3. Elaborate on the Broader Impacts section.


Grade:

1 Collier, James. Proposal Grading Rubric. Technical Writing. University of Vermont. Web. Aug. 1, 2012.
<http://www.faculty.english.vt.edu/Collier/3764/assign/proposal.htm#opt2>. Used with permission.