Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

NCT06215222 | Recruiting DMC

• 1 other identifier: IRB-62670
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

microbiome; Small intestine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules

  1-4 years

Study Arms (2)

Healthy patients

Healthy Patients

Other: Microbiota Sampling

IBS/Functional GI diasease

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

Other: Microbiota Sampling

Interventions

Microbiota Sampling OTHER

We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation

Healthy patients; IBS/Functional GI diasease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Digestive Health Clinic

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Central Study Contacts

Sean Spencer, MD,PhD

CONTACT

(650) 736-5555; seanspen@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: November 16, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

US (1)