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Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

Stanford University · NCT06215222

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
40
US sites recruiting
1
Study start
November 16, 2023
Record last updated
January 22, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Microbiota Sampling

Conditions: IBS - Irritable Bowel Syndrome; Healthy; Functional Bloating; Functional Gastrointestinal Disorders

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Stanford Digestive Health Clinic

    Redwood City, CA 94063

    Site contact: Sean Spencer, MD/PhD · 650-736-5555 · seanspen@stanford.edu

Study contacts (from the official record)

  • Sean Spencer, MD,PhD · (650) 736-5555 · seanspen@stanford.edu
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease (NCT06215222) | Bored Studies