Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

NCT ID: NCT06215222

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2026-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy patients

Healthy Patients

Microbiota Sampling

Intervention Type: OTHER

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)

Microbiota Sampling

Intervention Type: OTHER

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

Interventions

Microbiota Sampling

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sean Spencer

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Digestive Health Clinic

Redwood City, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sean Spencer, MD,PhD

Role: CONTACT

seanspen@stanford.edu

(650) 736-5555

Facility Contacts

Sean Spencer, MD/PhD

Role: primary

seanspen@stanford.edu

650-736-5555

Linda Nguyen, MD

Role: backup

(650) 736-5555

Other Identifiers

IRB-62670

Identifier Type: -

Identifier Source: org_study_id