Clinical trial: An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients (NCT00765401)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction