RECRUITING

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Conditions

IBS - Irritable Bowel Syndrome Healthy Functional Bloating Functional Gastrointestinal Disorders microbiome Small intestine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Quick Facts

Study Start:2023-11-16

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06215222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Sean Spencer, MD,PhD

CONTACT

(650) 736-5555

seanspen@stanford.edu

Study Locations (Sites)

Stanford Digestive Health Clinic

Redwood City, California, 94063

United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-11-16

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

microbiome
Small intestine

Additional Relevant MeSH Terms

IBS - Irritable Bowel Syndrome
Healthy
Functional Bloating
Functional Gastrointestinal Disorders