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

Withdrawn before enrolling

Conditions studied: Cystic Fibrosis, Abdominal Pain, Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT00765401

Run by

Penn State University

People needed

0

Starts

2008-11-01

Expected to finish

2011-04-01

Last updated by the study team

2017-11-24

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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).

You may not qualify if…

• 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.

Where it is running

• Penn State College of Medicine, Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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