Sampling gut bacteria in patients with IBS and functional gastrointestinal disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.