This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.
Males or females 18 years of age or older and 85 years of age or younger at the time of the first Screening Visit.
ASA Classification 1 or 2.
For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
prior gastric or esophageal surgery, including bariatric surgery
bowel obstruction
gastric outlet obstruction
gastroparesis
Single group
CapScan
DeviceGut sampling capsule
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
A primary endpoint is to identify and quantitate the relative abundance of the gut microbial taxa using at least 3 million metagenomic DNA sequencing reads in at least 75% of the samples obtained from the CapScan devices.
Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices
A primary endpoint is to identify at least 1,500 annotated gut metabolites from the intestinal tract in at least 75% of the samples obtained from the CapScan devices.
Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment
Evaluate the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of the study population from before and after omeprazole treatment.
Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment
Evaluate the diversity, centroids and distributions of gut metabolites in CapScan samples of the study population from before and after omeprazole treatment.
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