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GI Clinical Trials

C.Diff | Diabetic Gastroparesis | GERD

Clostridium Difficile Infection

Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection
Aims: The purpose of the study is to determine if Fecal Microbiota Transplantation (FMT) is effective in the treatment of recurrent Clostridium difficile infection (CDI). C. difficile is not only occurring more frequently, but there is also an epidemic of serious cases which are refractory to therapy and lead to more prolonged or recurrent illness.
Diagnosis: Recurrent or Refractory C. Difficile Infection
Principal Investigator: Eugene Yen, MD
IRB Approval Number: EH13-450
Sponsor: NorthShore University HealthSystem
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes

Fecal Microbiota Transplant (FMT) versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium difficile Infection
Aims: Our previous FMT research study has proven highly effective for the patient population infected with recurrent or refractory CDI. This study looks at administration of FMT at an earlier time point during a hospitalization (first or greater recurrence) to look for reduced relapses and reduced morbidity in FMT in comparison to standard antibiotic therapy.
Diagnosis: Recurrent Clostridium difficile Infection
Principal Investigator: Jennifer Grant, MD
IRB Approval Number: EH14-331
Sponsor: NorthShore University HealthSystem 
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes

PRISM: A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection
Aims: This study aims to evaluate the safety, tolerability, and efficacy of CP101 treatment compared to placebo in adults with previously treated recurrent CDI.
Diagnosis: Recurrent Clostridium difficile Infection
Principal Investigator: Eugene Yen, MD
IRB Approval Number: EH18-378
Sponsor: Finch Research and Development LLC
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: No


Diabetic Gastroparesis

RLM-MD-02: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
Aims: To compare the efficacy of relamorelin with placebo in participants with DG with respect to a composite of the following core signs and symptoms of Diabetic Gastroparesis: Nausea, Abdominal pain, postprandial fullness, bloating
Diagnosis: Diabetic Gastroparesis
Principal Investigator: Jay L. Goldstein, MD
IRB Approval Number: EH17-315
Sponsor: Allergan plc
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes


Gastroesophageal Reflux Disease (GERD)

C3718-301: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors
Aims: The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.
Diagnosis: Gastroesophageal Reflux Disease
Principal Investigator: Jay L. Goldstein, MD
IRB Approval Number: EH17-315
Sponsor: NorthShore University HealthSystem 
Contact: Karina Castro at 847.570.3708
Open to Enrollment: Yes