Skip to Content

GI Clinical Trials

The Role of Genotypic Clarithromycin Resistance Testing Using PCR Detection of 23S Mutations in Predicting Failure of Eradication of Helicobacter Pylori Infection with Standardized Clarithromycin Proton Pump Inhibitor (PPI) Based Triple Therapy
Aims: Helicobacter Pylori (H. Pylori) is a bacterium that infects the stomach and can cause peptic ulcers and stomach cancer.  Normally, H. pylori is tested for using a CLO test, a urease breath test, a stool antigen test, or tissue biopsy. In addition, the treatment for the bacteria typically consists of clarithromycin triple therapy. There is data that suggests the clarithromycin triple therapy may not cure H. pylori infections in up to 30% of cases in the United States. Therefore, the purpose of this study is to determine whether molecular tests done on H. pylori bacteria taken from stomach tissue can predict clarithromycin treatment failure. H. pylori can have genes that make it resistant to specific drugs. By testing stomach tissues (taken during an esophagogastroduodenoscopy or EGD), we will be able to determine whether H. pylori will respond to certain types of drugs.  
Diagnosis: H. Pylori Infection
Principal Investigator: Karen Kaul, MD, PhD
Other Investigators: Jay Goldstein, MD and Dena Shibib, DO
IRB Approval Number: EH 13-101
Sponsor: NorthShore University HealthSystem Department of Medicine and Department of Pathology
Contact: Interested patients should contact Obad Ansari at 847.570.3708
Open to Enrollment: Yes

Fecal Microbiota Transplantation (FMT)/Stool Transplant
Aims: C. Difficile is not only occurring more frequently, but there is also an epidemic of serious cases which are refractory to therapy and have high rates of colectomy and death. The use of antimicrobials may predispose patients to further relapses by disturbing intestinal flora and can contribute to the problem of drug resistance. FMT has been shown to restore phylogenetic richness and diversity of the intestinal microbiome thereby restoring colonization resistance. Dr. Yen and several Infectious Disease physicians oversee screening and scheduling patients who may qualify to receive a stool transplant.
Diagnosis: C. Difficile Infection 
Principal Investigator
: Eugene Yen, MD
Other Investigators: 
Jennifer Grant, MD, Leonard Kaplan, MD, Stephen Schrantz, MD, Jeffery Semel, MD, Shailesh Bajaj, MD, and David Labowitz, DO
IRB Approval Number: EH 13-450
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact study coordinator Naomi Adams at 847.570.3708
Open to Enrollment: Yes

Fecal Microbiota Transplant (FMT) Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium difficile Infection
Aims: C. Difficile is not only occurring more frequently, but there is also an epidemic of serious cases, which are refractory to therapy and have high rates of colectomy and death. The use of antimicrobials may predispose patients to further relapses by disturbing intestinal flora and can contribute to the problem of drug resistance. FMT has been shown to restore phylogenetic richness and diversity of the intestinal microbiome thereby restoring colonization resistance. Our previous FMT research study has proven highly effective for the patient population infected with recurrent or refractory CDI. Dr. Smith believes that administration of FMT at an earlier time point (first recurrence) will led to reduced relapses and reduced morbidity associated with those relapses in comparison to standard antibiotic therapy. The primary outcome will be clinical resolution of diarrhea without recurrence of CDI within 90 days.
Diagnosis: C. difficile infection 
Principal Investigator:  Jennifer Grant, MD
Other Investigators: Eugene Yen, MD, Nicole Gentile, MD, and Edward Schaefer, MD
IRB Approval Number:  EH 14-331
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact study coordinator Naomi Adams at 847.570.3708
Open to Enrollment: Yes

Utilizing Genetic Risk Score (GRS) to Supplement Existing Methods to Identify Subjects at Increaded Risk for Early Age-Onset of Colorectal Cancer
Aims: The purpose of this study is to examine the association of a gentic risk score (GRS) and other risk factors for colorectal cancer. A saliva sample will be obtained from research subjects for DNA testing. Samples will be obtained from subjects with and without colorectal cancer to determine a genetic risk score. The GRS may supplement existing methods to better identify patients at increased risk for colorectal cancer. Identifying this group of patients will allow physicians to recommend a screening colonoscopy before age 50 and/or more frequent screenings to these patients to prevent the onset of colorectal cancer. Patients who have had a screening colonoscopy within the last 5 years at NorthShore University HealhtSystem may be eligible to participate.
Diagnosis: None
Principal Investigator: 
Jay Goldstein, MD
Other Investigator: Laura Bianchi, MD and Jianfeng Xu, MD
IRB Approval Number: EH15-116
Sponsor:
NorthShore University HealthSystem
Contact:
Interested patients should contact study coordinator Obaid Ansari at 847.570.3708
Open to Enrollment:
Yes

RLM-MD-02: A 12 Week, Randomized, Double-Blinded, Placebo-Controlled, Phase 3-Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
Aims: The purpose of this clinical trial is to compare the efficacy of Relamorelin with placebo in subjects with Diabetic Gastroparesis with respect to the core symptoms of nausea, abdominal pain, postprandial fullness, and bloating.
Diagnosis: Diabetic Gastroparesis
Principal Investigator: Jay L. Goldstein, MD
Other Investigators: Michael Ujiki, MD, Eugene Yen, MD, Liana Billings, MD, David Labowitz, DO, Omar Khan, MD, Susan Taylor, NP
IRB Approval Number: EH17-315
Sponsor: Allergan
Contact: Interested patients should contact research coordinator Obaid Ansari at 847.570.3708
Open to Enrollment: Yes