About this trial
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
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.
Disqualifiers
Prior gastric or esophageal surgery, including lap banding or bariatric surgery
Bowel obstruction
Gastric outlet obstruction
Diverticulitis
Trial population
Healthy Subjects or those with clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
Trial design
Cohort
Prospective
Treatments tested in this trial
Microbiota Sampling
Other interventionWe will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation
Treatment groups
Trial outcomes
Primary outcomes
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
Collection of 50ul of intestinal fluid from microbiome sampling capsules
Secondary outcomes
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules
Isolation of liven bacteria from the intestinal fluid of \>90% of microbiome sampling capsules
Sponsors and contacts
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