Actively Recruiting
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Led by Stanford University · Updated on 2024-01-22
40
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
CONDITIONS
Official Title
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
You will not qualify if you...
- History of any of the following: prior gastric or esophageal surgery, including lap banding or bariatric surgery
- History of bowel obstruction
- History of gastric outlet obstruction
- History of diverticulitis
- History of inflammatory bowel disease
- History of ileostomy or colostomy
- History of gastric or esophageal cancer
- History of achalasia
- History of esophageal diverticulum
- Active Dysphagia or Odynophagia
- Active medication use for any gastrointestinal conditions
- 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
- Any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford Digestive Health Clinic
Redwood City, California, United States, 94063
Actively Recruiting
Research Team
S
Sean Spencer, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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