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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02769637
• Date of registration: 10/05/2016
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
• Scientific title: Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
• Date of first enrolment: September 7, 2017
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02769637
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Sophie Fillon, PhD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion 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%



Age minimum: 10 Years
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: PPI treatment

Primary Outcome(s)

Changes in the microbiota and inflammation [Time Frame: Baseline and 6 weeks]

Secondary ID(s)

16-0672

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation