Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Functional Gastrointestinal Disorders; IBS - Irritable Bowel Syndrome; Functional Bloating
• Intervention / Treatment: Other: Microbiota Sampling

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Sean Spencer, MD,PhD; Phone Number: (650) 736-5555; Email: seanspen@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Digestive Health Clinic
      • Contact: Sean Spencer, MD/PhD; Phone Number: 650-736-5555; Email: seanspen@stanford.edu
      • Contact: Linda Nguyen, MD; Phone Number: (650) 736-5555
      • Principal Investigator: Sean Spencer, MD/PhD
      • Principal Investigator: Linda Nugyen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Subjects or those with clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy patients; Healthy Patients	Other: Microbiota Sampling; We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation
IBS/Functional GI diasease; Patients with IBS or Functional GI disease (bloating, diarrhea, constipation)	Other: Microbiota Sampling; We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules	Collection of 50ul of intestinal fluid from microbiome sampling capsules	1-4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules	Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules	1-4 years

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: microbiome; Small intestine
• Additional Relevant MeSH Terms: Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: IRB-62670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No