Actively Recruiting
Capsule Microbiota Sampling in IBS and Functional Gastrointestinal Disease
Led by Stanford University · Updated on 2024-01-22
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the intestinal microbiota in healthy individuals and those with Irritable Bowel Syndrome (IBS) or functional gastrointestinal diseases such as bloating, diarrhea, and constipation. The study aims to collect and analyze samples from the intestinal microbiome to better understand these conditions. Participants include adults aged 18 to 70 years who meet specific health criteria and symptom profiles. The study involves sampling saliva, feces, and intestinal microbiota using a microbiome sampling capsule. This capsule is designed to collect intestinal fluid, and the goal is to successfully collect 50 microliters of fluid from over 90% of capsules used. Participants include both healthy individuals and those diagnosed with IBS or functional gastrointestinal disorders. The study does not involve drug treatments but focuses on observational sampling and analysis. Participants will provide samples of saliva, feces, and intestinal fluid collected by the capsule. The study includes monitoring for the presence of live bacteria in these samples. Participants must comply with study requirements including pregnancy testing and contraceptive use if applicable. Researchers will evaluate the quality and quantity of samples collected over a study period lasting from one to four years. Safety and adherence are monitored throughout the study with no intervention-based treatments administered.
CONDITIONS
Brief 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 (normal healthy or 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 if applicable
- Fluent in English, understands the study protocol and consent, and able to comply with study requirements
- Positive for at least one clinical symptom consistent with SIBO, IBS, or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
You will not qualify if you...
- History of prior gastric or esophageal surgery, including lap banding or bariatric surgery
- History of bowel obstruction or gastric outlet obstruction
- History of diverticulitis or inflammatory bowel disease
- History of ileostomy or colostomy
- History of gastric or esophageal cancer
- History of achalasia or esophageal diverticulum
- Active dysphagia or odynophagia
- Active medication use for any gastrointestinal conditions
- Pregnancy or planned pregnancy within 30 days, or breast-feeding
- Any active substance abuse or dependence, unstable medical or psychiatric disorder
- Any chronic condition that may interfere with study conduct as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments and eligibility confirmation
Duration - 1 to 4 years
Participants provide saliva, feces, and intestinal fluid samples using microbiome sampling capsules for genetic microbiome analysis and bacterial isolation.
Visits occur as needed for sample collection and capsule retrieval
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
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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