Functional Dyspepsia


Probe-based confocal laser endomicroscopy to detect structural and functional duodenal mucosal abnormalities in patients with functional dyspepsia (FD): Understanding the mechanisms generating symptoms in functional dyspepsia

IRB# HUM00112343

Purpose

The lining of the small bowel will be evaluated at microscopic level in individuals with symptomatic functional dyspepsia (FD) and healthy individuals without gastrointestinal symptoms using the confocal laser endomicroscopy (CLE) technique, which is applied through a routine upper endoscopy (esophagogastroduodenoscopy [EGD]). CLE is a new technique capable of dynamic visualization of architectural changes of the gut mucosa at a microscopic level.

Subject Eligibility

  • Subjects 18 years of age or older
  • Female subjects must not be pregnant and must use a reliable contraception method
  • Must not be on a special or restricted diet (e.g., gluten-free, lactose-free, or low FODMAP)
  • Must not have recent weight loss, family history of gastrointestinal cancer, or worsening swallowing problems
  • Must not have uncontrolled reflux disease (e.g., frequent heartburn with regurgitation, chronic cough) or active gallbladder disease
  • Must not be taking antiinflammatory drugs (like Motrin, Ibuprofen, Advil, Aspirin)
  • Must not have history of peptic ulcer disease or erosive esophagitis
  • Must not have inflammatory bowel disease, small intestinal bacterial overgrowth, gastrointestinal bleeding, or pancreatitis
  • Must not have any medical condition known to affect the gastrointestinal system (e.g., scleroderma, unstable thyroid disease, uncontrolled diabetes mellitus), cancer, severe kidney or liver disease
  • Must not have history of previous surgery in the gastrointestinal tract, except appendectomy or cholecystectomy if performed more than 6 months prior to participating in the study
  • FD subjects must have at least one of the following symptoms of indigestion for at least 6 months duration:
    • Belly pain or burning
    • Feeling full shortly after eating
    • Inability to finish a normal sized meal

Description

Study will require 2 visits over a period of 2 to 4 weeks. First visit subjects will be screened to determine eligibility and consent. Participants with FD will go through a 2-week screening period, during which the severity of their dyspeptic symptoms will be assessed and eligibility determined. All eligible subjects will undergo an EGD with CLE on visit 2. FD subjects will be responsible for the EGD procedure charges.

Compensation: $150

Expected Recruitment End Date: November 2018

Principal Investigator: Borko Nojkov, MD

Study Coordinator: Lina, Email: functional-GI-disorder@med.umich.edu, (link sends e-mail) Phone: (734) 936-2761