The Effect of PPI Therapy on Weight, Gut Microbiome, and Expression of GPR41 and GPR43

Status unconfirmed

Conditions studied: Gastroesophageal Reflux Disease, Obesity

In brief

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).

Key facts

Study ID

NCT02457104

Run by

University of Colorado, Denver

People needed

120

Starts

2015-06-01

Expected to finish

2021-12-01

Last updated by the study team

2021-02-18

Who can join

Age: 40 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• asymptomatic (no complaints of abdominal pain, diarrhea, blood in stools, constipation, etc.)
• age 40-59 years
• 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)
• BMI that is either normal-weight (BMI of 18.5-<25 kg/m2) or Class I/ II obese (BMI of 30-<40 kg/m2).

You may not qualify if…

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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.