Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Healthy Clinical Trial

Official title:

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215222
• Other study ID #: IRB-62670
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Sean Spencer, MD,PhD
• Phone: (650) 736-5555
• Email: seanspen[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Healthy
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Other:
• Microbiota Sampling
We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation

Locations

Country	Name	City	State
United States	Stanford Digestive Health Clinic	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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