Research

The faculty of Gastroenterology and Hepatology are actively pursuing research in gastrointestinal and hepatological diseases from bench to bedside and to the community. Diverse topics are under study. These include:

  • Inflammation of the GI tract involving the esophagus (gastroesophageal reflux disease, eosinophilic esophagitis) and the small and large intestine (Crohn's and Ulcerative Colitis, Jejunoileitis)
  • Motility disorders of the GI tract (achalasia, sphincter of Oddi dysfunction)
  • Reflux related airway disorders and protective mechanisms against aspiration
  • Intestinal sensory physiology (brain-gut interaction, afferent nerve pathobiology)
  • Pathobiology of reflux disease
  • Diseases of the pancreas and biliary tract (cancer palliation, newer diagnostic modalities)
  • Infectious diseases of the liver (hepatitis A, B, C), cirrhosis and portal hypertension, hepatic encephalopathy
  • Intestinal absorption specifically vitamin B12

These studies are supported by a number of federal agencies including the National Institutes of Health and the Veteran's Affairs Administration, and private foundations such as the Crohn’s and Colitis Foundation of America, Philanthropy, as well as industry.

Clinical Trials

Open AllClose All
  Inflammatory Bowel Disease

A Long-term, Non-interventional Registry to Assess Safety and Effectiveness of Humira (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD). Principal Investigator: Daniel Stein, MD

SECURE: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease. Status: Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

Millennium: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease. Principal Investigator: Daniel Stein, MD

LEGACY: A Long-term, Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC). Principal Investigator: Daniel Stein, MD

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. Principal Investigator: Daniel Stein, MD

A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration. Principal Investigator: Daniel Stein, MD

A Double-blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. Principal Investigator: Daniel Stein, MD

A Multicenter, Open-label Study to Evaluate the Long-term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Principal Investigator: Daniel Stein, MD

Phase III, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who are Refractory to or Intolerant of TNF Inhibitors. Principal Investigator: Daniel Stein, MD

Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared with Placebo in Patients with Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors. Principal Investigator: Daniel Stein, MD

An Open-label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase III Studies. Principal Investigator: Daniel Stein, MD

  Hepatology

STOP-HE Study: Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenyl acetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy. Principal Investigator: Kia Saeian, MD

  Pancreaticobiliary

CLARITY: Clinical Investigation to evaluate removal of the Evolution® esophageal stent–fully covered. Principal Investigator: Kulwinder Dua, MD

Randomized, Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients with Pancreatic Cancer. Principal Investigator: Kulwinder Dua, MD

Evolve: Prospective, Multicenter, Single-blind, Randomized Study Comparing the EndoMAXX EVT Fully Covered Esophageal Stent with Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction. Principal Investigator: Kulwinder Dua, MD

Research Protocols

If you are interested in participating in a research protocol, please call our Gastroenterology Research Laboratory at (414) 805-3827.

Open AllClose All
  Esophageal Motor Function in Health and Disease {PRO00000170}

Investigate pharyngoesophageal and laryngeal function in health and disease as it relates to gastroesophagopharyngeal reflux and aspiration. Healthy controls and volunteers with certain gastroesophageal conditions may participate in various types of studies. Principal Investigator: Reza Shaker, MD

  Cerebral Cortical Representation of Gut-Sensory Motor Function (PRO00000174}

In-depth investigation of cerebral cortical (brain) representation of digestive tract sensory/motor function in health and disease. We are recruiting IBS patients, CVS patients, Dyspepsia patients, and healthy volunteers for this MRI study. Principal Investigator: Reza Shaker, MD

  Comparison of Gene Expression Patterns Between Patients with Erosive and Nonerosive Phenotype Gastroesophageal Reflux Disease {PRO00000180}

Understand the genetic variations in phenotypically different patients (normal squamous esophageal mucosa, esophagitis, or Barrett's esophagus and esophageal cancer). Study procedures may involve transnasal endoscopy or conventional endoscopy, biopsy, collection of waste esophagectomy tissue, acid perfusion, or taking a medication such as Nexium or Prilosec. Principal Investigator: Reza Shaker, MD

  Esophageal Motor Function in Health and Disease: Sensory Implications {PRO00000895}

Comprehensive investigation of region-specific neural and neurocognitive cerebrocortical responses to esophageal viscerosensation in health and disease. Healthy controls and patients with sensory and organic esophageal disorders due to acid reflux will undergo several procedures. Principal Investigator: Reza Shaker, MD

  Mechanisms for Prevention of Aspiration

Three aims: Characterize aerodigestive reflexes preventing aspiration. Characterize esophageal reflexes preventing aspiration. Characterize upper GI pressure responses to cough and phonation. We are recruiting smokers and nonsmokers. Principal Investigator: Kulwinder Dua, MD

  External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease (PRO00014424}

Investigate the effect of an external band placed just below the Adam’s apple on symptoms of esophageal reflux into the throat. It is thought that this band can increase pressure in the opening of the food pipe, thereby reducing acid in the throat in patients with certain gastroesophageal conditions. Principal Investigator: Reza Shaker, MD

  Resting State Connectivity and Cirrhosis {PRO00015184}

Investigate which parts of the brain are affected by cirrhosis of the liver at rest and when undergoing a task related to memory. Patients with cirrhosis of the liver and healthy volunteers may undergo MRI scanning and pen and paper cognitive functioning testing. Principal Investigator: Reza Shaker, MD

Contact Us

Division of Gastroenterology and Hepatology
Department of Medicine
9200 W. Wisconsin Ave.
Milwaukee, WI 53226

(414) 955-6830 | gastro@mcw.edu

Gastroenterology and Hepatology Clinic
(414) 805-2901
Clinic Contact Information

Froedtert Hospital's Gastroenterology and Hepatology Services

Top