An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients
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|ClinicalTrials.gov Identifier: NCT00765401|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : October 2, 2008
Last Update Posted : November 24, 2017
Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians. While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases occur in >95% of CF individuals and can contribute to significant morbidity, mortality and a decreased quality of life. The abdominal pain in CF is usual chronic in nature, and the etiology is not usually found, despite medical testing for standard causes of abdominal pain. Helicobacter pylori (Hp) is increasingly being recognized as the etiology of peptic ulcer disease and other upper and lower gastrointestinal tract diseases.1 The role that Hp plays in CF abdominal pain has not been elucidated.
Our long-term goal is to understand relationship between chronic HP infection and abdominal pain in pediatric CF patients.
The specific objective of this proposal is to utilize current state-of-the-art testing for HP to determine the prevalence of Hp in our CF patients age 5 and older.
The central hypothesis is that Cystic fibrosis subjects with significant abdominal pain will have an increased incidence of Helicobacter pylori as determined by the urea breath test and stool antigen test.
The rationale for the proposed research is that once we elucidate a causal relationship between CF patients with abdominal pain and Hp, we can begin treatment of this infection to improve quality of life.
|Condition or disease|
|Cystic Fibrosis Abdominal Pain Helicobacter Pylori Infection|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients|
|Actual Study Start Date :||November 2008|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
U.S. FDA Resources
The subject with positive breath Test for H.pylori and/or positive stool antigen test
The subject with negative breath Test for H.pylori and negative stool antigen test
- To determine the incidence of Helicobacter pylori in pediatric CF patients. [ Time Frame: About a year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765401
|United States, Pennsylvania|
|Penn State College of Medicine, Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|