NCT02769637

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

May 10, 2016

Last Update Submit

June 25, 2018

Conditions

Cystic Fibrosis

Keywords

upper gastrointestinal tractlung microbiota and inflammation

Outcome Measures

Primary Outcomes (1)

  • Changes in the microbiota and inflammation

    Identification of bacterial communities and IL-8

    Baseline and 6 weeks

Study Arms (2)

ON PPI

Subjects on proton pump inhibitor (PPI) treatment

Drug: PPI treatment

OFF PPI

Subjects off proton pump inhibitor (PPI) treatment

Interventions

PPI treatmentDRUG

PPI treatment or no PPI treatment

Also known as: Acid blockade medication
ON PPI

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects with Cystic Fibrosis

You may qualify if:

  • Ages 10-21 years
  • Known diagnosis of CF based on sweat chloride \> 60 mEq/L or identification of two known Cystic fibrosis transmembrane conductance regulator (CFTR) mutations
  • Clinically stable pulmonary disease defined by
  • clinical impression of patient's primary CF provider,
  • no newly prescribed antibiotic treatments in the 30 days prior to enrollment, and
  • relativly stable lung function with a forced expiratory volume in 1 second (FEV1) within 10% of baseline.
  • Male and female
  • Willing to participate in and comply with all study procedures, and
  • Willingness of the subject, parent or legally authorized representative to provide written informed consent.
  • Body Mass Index (BMI) \>25%
  • \>40% FEV1.
  • Willing to stop acid blockade medication for 6 weeks for aim 1.
  • Not on acid blockade for 6 weeks for aim 2.

You may not qualify if:

  • FEV1 less than 40% predicted
  • History of meconium ileus, distal intestinal obstructive syndrome, gastrointestinal surgery, or intestinal stricture.
  • CF liver disease with cirrhosis, gastric or esophageal varices.
  • Unwilling to participate in and comply with the study procedures.
  • Unwillingness of the subject, parent or legally authorized representative to provide written informed consent.
  • Unwilling or unable to swallow the capsule with the esophageal string test (EST).
  • Gelatin allergy.
  • History of esophageal surgery including fundoplication, or
  • Presence of a gastrostomy tube.
  • Confirmed or suspected diagnosis of Gastroesophageal Reflux Disease (GERD)
  • BMI \< 25%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA for 16S amplification

MeSH Terms

Conditions

Cystic FibrosisInflammation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie Fillon, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 11, 2016

Study Start

September 7, 2017

Primary Completion

January 18, 2018

Study Completion

January 18, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)