The Effect of PPI Therapy on Weight, Gut Microbiome, and Expression of GPR41 and GPR43
1 other identifier
observational
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 18, 2021
February 1, 2021
6.3 years
May 27, 2015
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Gut microbiota
The primary aim of this study is to examine the effect of PPI therapy on the gut microbiota in the colon and terminal ileum of normal weight and obese patients.
Within 3 months of colonoscopy
Secondary Outcomes (1)
Gut bacterial RNA dedicated to the fermentation cycle
within 3 month of colonoscopy.
Other Outcomes (1)
GPR41, GPR43 expression
within 3 months of colonoscopy
Study Arms (4)
normal weight individuals not taking PPI
normal weight individuals taking PPI
obese individuals not taking PPI
obese individuals taking PPI
Interventions
Patients selected from those undergoing screening colonoscopy. During colonoscopy, stool aspirates and biopsies will be taken from the terminal ileum, cecum, and sigmoid colon.
Brief questionnaire outlining weight history, type and dose of PPI, and diet.
Eligibility Criteria
We will select four groups of patients presenting for colonoscopy to participate in this study: normal weight individuals not taking PPI, normal weight individuals taking PPI, obese individuals not taking PPI, and obese individuals taking PPI.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Biospecimen
Stool aspirate will be frozen (temporarily "banked") until a sufficient number of samples is available to analyze the microbiome in a cost-effective manner. The samples will not be saved after this microbiome analysis for any future analysis. The colonic and small intestinal mucosal tissue will be frozen. The colonic and small instestinal samples will be used for RNA isolation as a part of this study. The remainder of the sample will be banked for possible future use.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Czwornog, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
May 29, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02