Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Launched by STANFORD UNIVERSITY · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the bacteria in the intestines of people with Irritable Bowel Syndrome (IBS) and other digestive issues. Researchers will use a special capsule to collect samples of these bacteria from participants. They are looking for individuals aged between 18 and 70 who have experienced symptoms related to IBS or other functional gastrointestinal disorders. Participants should be in good health or have mild systemic diseases, and women must not be pregnant or breastfeeding.

If you decide to join this study, you will be asked to take the capsule, which is designed to gather information about your gut bacteria. The trial is currently recruiting participants, and it’s important to note that those with certain medical histories, such as previous surgeries on the stomach or intestines, or those experiencing specific gastrointestinal problems, may not be eligible. Overall, this study aims to gain insights that could help improve treatment for IBS and similar conditions.

Gender

ALL

Eligibility 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