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Recruiting

NCT Number: NCT06215222

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Digestive Health Clinic

Redwood City, California, 94063, United States

Location status: Recruiting

Location contact

Linda Nguyen, MD

CONTACT

(650) 736-5555

Linda Nugyen, MD

PRINCIPAL_INVESTIGATOR

Sean Spencer, MD/PhD

CONTACT

[email protected]

650-736-5555

Sean Spencer, MD/PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiota Sampling

Other

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

Primary outcomes

  1. Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules

    Time frame: 1-4 years

    Collection of 50ul of intestinal fluid from microbiome sampling capsules

Secondary outcomes

  1. Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules

    Time frame: 1-4 years

    Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Spencer, MD,PhD

CONTACT

[email protected]

(650) 736-5555

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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