Recruiting

PPI Therapy

Sponsor:

University of Colorado, Denver

Code:

NCT02457104

Conditions

Gastroesophageal Reflux Disease

Obesity

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

Interventions

Colonoscopy

Weight and diet questionnaire

Study Details

Brief summary:

The investigators long-term goal is to understand how PPIs influence energy balance in both obese and normal-weight individuals. The overall goal of this study is to determine whether PPI use causes detrimental changes in the composition and functional properties of the gut microbiome, and whether any such effects are mediated by altered responses of human fatty acid receptors (e.g., GPR41/43).

Conditions

Gastroesophageal Reflux Disease

Obesity

Study ID

NCT02457104

Start date

Jun, 2015

Status verified date

Feb, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Oct, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 59

Healthy Volunteers: Accepted

Inclusion Criteria:

1. asymptomatic (no complaints of abdominal pain, diarrhea, blood in stools, constipation, etc.)
2. age 40-59 years
3. PPI users (Use of a PPI for ≥ 4 days/week for the preceding 8 weeks) or non-users of acid suppressing medications (no use of a PPI or H2B for the previous 8 weeks)
4. BMI that is either normal-weight (BMI of 18.5-<25 kg/m2) or Class I/ II obese (BMI of 30-<40 kg/m2).

Exclusion Criteria:

1. probiotic or antibiotic use within 3 months of the colonoscopy
2. inflammatory bowel disease
3. personal history of colon cancer
4. resection of any portion of the gastrointestinal tract (including appendectomy and cholecystectomy)
5. diabetes
6. Significant motility disorders of the GI tract (e.g., gastroparesis, colonic inertia)
7. Use of immunosuppressive medications within the past 6 months
8. pregnancy/lactation
9. HIV or other immune deficiencies
10. prisoners

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

normal weight individuals not taking PPI

normal weight individuals taking PPI

obese individuals not taking PPI

obese individuals taking PPI

Interventions

Colonoscopy

Patients selected from those undergoing screening colonoscopy. During colonoscopy, stool aspirates and biopsies will be taken from the terminal ileum, cecum, and sigmoid colon.

Weight and diet questionnaire

Brief questionnaire outlining weight history, type and dose of PPI, and diet.

Primary outcome measure

  • Gut microbiota [ Time Frame: Within 3 months of colonoscopy ]

Central Contacts and Locations

Central contacts

Jennifer Czwornog, MD

jennifer.czwornog@ucdenver.edu

Gregory Austin, MD

303-724-1857gregory.austin@ucdenver.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 18, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2021-02-18.