An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients
Recruitment status was Not yet recruiting
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Purpose
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 |
|---|
|
Cystic Fibrosis Abdominal Pain Helicobacter Pylori Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients |
- To determine the incidence of Helicobacter pylori in pediatric CF patients. [ Time Frame: About a year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 42 |
| Study Start Date: | November 2008 |
| Groups/Cohorts |
|---|
| 1 |
| 2 |
|
Group A
The subject with positive breath Test for H.pylori and/or positive stool antigen test
|
|
Group B
The subject with negative breath Test for H.pylori and negative stool antigen test
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be enrolled from CF population seen at the Milton S. Hershey Medical Center CF center if they meet the inclusion and exclusion criteria at their scheduled out patient visit to CF clinic.
Inclusion Criteria:
- Confirmed diagnosis of CF by a positive sweat test (more than or equal to 60 mEg/L by quantitative pilocarpine iontophoresis and/ or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with CF phenotype)
- Abdominal pain during last 6 months
- Age > 5 and <18 years
- Either gender
4. Ability to do urea breath test which requires drinking water based solution through a straw and breathing into a breath sample bag 5. Must be off any oral antibiotics and proton pump inhibitors or sucralfate for 14 days.
Subject may continue their prophylactic (X 3/ week) dose of Azithromycin). Patients who are currently on antibiotics or have been on antibiotics within 14 days will be re-screened for inclusion criteria at their next clinic visit (i.e. no wash out).
Exclusion Criteria:
- Females of child bearing potential with a positive urine pregnancy test The decision not to include pregnant females is based on: 1) the quality of life screens are not designed for pregnancy, 2) their abdominal complaints may be related to pregnancy, 3) safety of the breath test has not been established during pregnancy.
- Inability to do urea breath test which requires drinking water based solution through a straw and breathing into a breath sample bag.
Contacts and Locations| Contact: Muhammad Azim Qureshi, MD | 717-531-5901 | mqureshi@psu.edu |
| Contact: Carl B Rountree, MD | 717-531-5901 | crountree@psu.edu |
| United States, Pennsylvania | |
| Penn State College of Medicine, Milton S. Hershey Medical Center | Not yet recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: Muhammad Azim Qureshi, MD | |
More Information
No publications provided
| Responsible Party: | Muhammad Azim Qureshi, Assistant Professor Pediatrics, Penn State College of Medicine, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00765401 History of Changes |
| Other Study ID Numbers: | 29239 |
| Study First Received: | September 30, 2008 |
| Last Updated: | September 30, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penn State University:
|
Abdominal Pain Cystic Fibrosis H. pylori Children |
Additional relevant MeSH terms:
|
Pancreatic Diseases Abdominal Pain Cystic Fibrosis Fibrosis Helicobacter Infections Pain Signs and Symptoms Signs and Symptoms, Digestive |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013