Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Recruiting

• Conditions: Healthy; Functional Bloating; Functional Gastrointestinal Disorders; IBS - Irritable Bowel Syndrome
• Interventions: Other: Microbiota Sampling

• Registration Number: NCT06215222
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy patients	Microbiota Sampling	Healthy Patients
IBS/Functional GI diasease	Microbiota Sampling	Patients with IBS or Functional GI disease (bloating, diarrhea, constipation)

Primary Outcome Measures

Name	Time	Method
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules	1-4 years	Collection of 50ul of intestinal fluid from microbiome sampling capsules

Secondary Outcome Measures

Name	Time	Method
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules	1-4 years	Isolation of liven bacteria from the intestinal fluid of \>90% of microbiome sampling capsules

Trial Locations

Locations (1)

Stanford Digestive Health Clinic; 🇺🇸 Redwood City, California, United States