An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Penn State University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00765401
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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
Study Population

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.

Criteria

Inclusion Criteria:

  1. 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)
  2. Abdominal pain during last 6 months
  3. Age > 5 and <18 years
  4. 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:

  1. 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.
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765401

Contacts
Contact: Muhammad Azim Qureshi, MD 717-531-5901 mqureshi@psu.edu
Contact: Carl B Rountree, MD 717-531-5901 crountree@psu.edu

Locations
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         
Sponsors and Collaborators
Penn State University
  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:
Abdominal Pain
Cystic Fibrosis
Fibrosis
Helicobacter Infections
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Pancreatic Diseases
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 August 19, 2014