Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)

• Status: Terminated
• Trial end date: 2018-01-18
• Target enrollment: 0
• Participant gender: All

Summary

Mucus in the airways of patients with CF represents an area for bacteria proliferation, microbial infection and inflammation. Similar to the lung, the esophagus provides an environment for bacterial to grow. The overall goal of this proposal is to characterize the esophageal microbiota of children with CF that are treated or untreated with acid blockade medication and to measure its possible impact on respiratory disease to develop novel treatment strategies.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Proton Pump Inhibitors

Criteria

Inclusion Criteria:

1. Ages 10-21 years

2. Known diagnosis of CF based on sweat chloride > 60 mEq/L or identification of two known Cystic fibrosis transmembrane conductance regulator (CFTR) mutations

3. Clinically stable pulmonary disease defined by

1. clinical impression of patient's primary CF provider,

2. no newly prescribed antibiotic treatments in the 30 days prior to enrollment, and

3. relativly stable lung function with a forced expiratory volume in 1 second (FEV1) within 10% of baseline.

4. Male and female

5. Willing to participate in and comply with all study procedures, and

6. Willingness of the subject, parent or legally authorized representative to provide written informed consent.

7. Body Mass Index (BMI) >25%

8. >40% FEV1.

9. Willing to stop acid blockade medication for 6 weeks for aim 1.

10. Not on acid blockade for 6 weeks for aim 2.

Exclusion Criteria:

1. FEV1 less than 40% predicted

2. History of meconium ileus, distal intestinal obstructive syndrome, gastrointestinal surgery, or intestinal stricture.

3. CF liver disease with cirrhosis, gastric or esophageal varices.

4. Unwilling to participate in and comply with the study procedures.

5. Unwillingness of the subject, parent or legally authorized representative to provide written informed consent.

6. Unwilling or unable to swallow the capsule with the esophageal string test (EST).

7. Gelatin allergy.

8. History of esophageal surgery including fundoplication, or

9. Presence of a gastrostomy tube.

10. Confirmed or suspected diagnosis of Gastroesophageal Reflux Disease (GERD)

11. BMI < 25%