Sampling gut bacteria in patients with IBS and functional gastrointestinal disorders
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
This study is trying to collect gut bacteria samples from people with Irritable Bowel Syndrome and other digestive issues to see how their microbiome differs from healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT06215222 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect intestinal microbiota samples using a specialized microbiome sampling capsule from individuals diagnosed with Irritable Bowel Syndrome (IBS), functional bloating, and other functional gastrointestinal disorders, as well as healthy participants. The study will include adults aged 18 to 70 who meet specific inclusion criteria, such as having symptoms consistent with small intestinal bacterial overgrowth (SIBO) or IBS. Participants will be monitored to understand the microbiome's role in these conditions and how it may differ between healthy individuals and those with gastrointestinal disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with symptoms consistent with IBS or functional gastrointestinal disorders.
Not a fit: Patients with a history of significant gastrointestinal surgeries or other severe gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of the gut microbiome's role in IBS and related disorders, potentially leading to improved diagnostic and treatment strategies.
How similar studies have performed: Other studies have shown promising results in understanding the microbiome's impact on gastrointestinal health, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * History of any of the following: * Prior gastric or esophageal surgery, including lap banding or bariatric surgery * Bowel obstruction * Gastric outlet obstruction * Diverticulitis * Inflammatory bowel disease * Ileostomy or colostomy * Gastric or esophageal cancer * Achalasia * 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, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
Where this trial is running
Redwood City, California
- Stanford Digestive Health Clinic — Redwood City, California, United States (Recruiting)
Study contacts
- Study coordinator: Sean Spencer, MD,PhD
- Email: seanspen@stanford.edu
- Phone: (650) 736-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.