An Open-Label, Pilot Study Designed To Evaluate The Effect Of A Proton Pump Inhibitor On The Regional Composition Of The Gut Microbiota And Metabolic Profiles Of Health Volunteers Using The Capscan® Samplng Capsule
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Envivo Bio Inc
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
Study Overview
Brief Summary
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.
Detailed Description
Prospective, open-label, single-arm, non-randomized, single-center study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must meet all of the following criteria to be included in the study:
- •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
- •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.
Exclusion Criteria
- •Subjects with any of the following conditions or characteristics must be excluded from the study:
- •History of any of the following:
- •prior gastric or esophageal surgery, including bariatric surgery
- •bowel obstruction
- •gastric outlet obstruction
- •gastroparesis
- •acute diverticulitis
- •inflammatory bowel disease
- •ileostomy or colostomy
- •gastric or esophageal cancer
- •achalasia
- •active dysphagia or odynophagia
- •Daily PPI use in the last 30 days
- •Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- •Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
- •A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Outcomes
Primary Outcomes
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
Time Frame: 2 months
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
Time Frame: 2 months
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.
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
Time Frame: 2 months
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
Time Frame: 2 months
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.
Secondary Outcomes
- Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment(2 months)
- Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment(2 months)
- Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment(2 months)
- Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment(2 months)