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Capsule Microbiota Sampling in IBS and Functional GI Disorders

This study is looking at how to best collect samples of the tiny organisms (microbiota) living in your gut using a special capsule. Researchers will collect samples from saliva, stool (feces), and the gut itself for genetic analysis. The study includes healthy volunteers, people with Irritable Bowel Syndrome (IBS), and those with other functional gastrointestinal disorders like bloating. The main goal is to see if the capsule can successfully collect at least 50 microliters of intestinal fluid in over 90% of cases. This study is currently recruiting 40 participants, aged 18 to 70 years old, who are generally healthy.

Study design
This is an observational study involving 40 participants. It is not specified if participants are randomly assigned to groups or if the study is blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of collecting intestinal fluid will be measured over 1 to 4 years.

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NCT06215222

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Recruiting
Not specifiedAges 18–70Observational
Stanford University
~40 participants
Updated 2024-01-22 on ClinicalTrials.gov
What's tested:Microbiota Sampling

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
Measured over 1-4 years

Conditions

IBS - Irritable Bowel Syndrome
Healthy
Functional Bloating
Functional Gastrointestinal Disorders

Explore related trials

Functional disorder of gastrointestinal tractIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
California1

Who to contact

Sean Spencer, MD,PhD
[email protected]
(650) 736-5555
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules1-4 years

    Collection of 50ul of intestinal fluid from microbiome sampling capsules