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Recruiting NCT06215222

Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

— Observational IBS - Irritable Bowel Syndrome Healthy Functional Bloating Functional Gastrointestinal Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microbiota Sampling.
Who it may be relevant to
Registry conditions: IBS - Irritable Bowel Syndrome, Healthy, Functional Bloating, Functional Gastrointestinal Disorders. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other Microbiota Sampling
    We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation

Primary outcome measures

  • Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules [Time frame: 1-4 years]
Secondary outcome measures (1)
  • Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules [Time frame: 1-4 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Stanford Digestive Health Clinic — Redwood City

Identifiers

NCT: NCT06215222 · IRB-62670

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗