Status:
WITHDRAWN
An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients
Lead Sponsor:
Penn State University
Conditions:
Cystic Fibrosis
Abdominal Pain
Eligibility:
All Genders
5-18 years
Brief Summary
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% ...
Detailed Description
Abdominal pain and Cystic Fibrosis Cystic fibrosis is the most common lethal autosomal recessive disease among Caucasians. CF is caused by a single gene mutation on chromosome 7, which encodes for a m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00765401
Start Date
November 1 2008
End Date
April 1 2011
Last Update
November 24 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State College of Medicine, Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033