Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Stanford University

Status: Enrolling

Conditions: Healthy; Functional Gastrointestinal Disorders; Functional Bloating; IBS - Irritable Bowel Syndrome

Treatments: Other: Microbiota Sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06215222

IRB-62670

Details and patient eligibility

About

We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Healthy patients

Description:

Healthy Patients

Treatment:

Other: Microbiota Sampling

IBS/Functional GI diasease

Description:

Patients with IBS or Functional GI disease (bloating, diarrhea, constipation)

Treatment:

Other: Microbiota Sampling