Recruiting

Microbiota Sampling

Sponsor:

Stanford University

Code:

NCT06215222

Conditions

IBS - Irritable Bowel Syndrome

Healthy

Functional Bloating

Functional Gastrointestinal Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Microbiota Sampling

Study Details

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 ID

NCT06215222

Start date

Nov 16, 2023

Status verified date

Jan, 2024

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy patients

Healthy Patients

IBS/Functional GI diasease

Patients with IBS or Functional GI disease (bloating, diarrhea, constipation)

Interventions

Microbiota Sampling

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

Primary outcome measure

  • Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules [ Time Frame: 1-4 years ]

Central Contacts and Locations

Central contacts

Sean Spencer, MD,PhD

(650) 736-5555seanspen@stanford.edu

Locations

Stanford Digestive Health Clinic

Recruiting

Redwood City, California, United States, 94063

Contacts

Sean Spencer, MD/PhD

650-736-5555seanspen@stanford.edu

Linda Nguyen, MD

(650) 736-5555

Principal Investigator:

Sean Spencer, MD/PhD

More Information

Sponsor

Stanford University

Last update posted

Jan 22, 2024

Last verified

Jan, 2024

Keywords

  • microbiome
  • Small intestine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-01-22.