Inflammatory Bowel Disease is constantly changing and medical advances open new doors for more effective management. NorthShore participates in multiple clinical trials in an effort to bring our patients the newest available options in care. Below are the clinical research trials we are participating in that investigate new mechanisms for patients who are not responding to conventional therapies. Please discuss with your doctor to see if any of these trials may be right for you. If you have any questions, please contact the individual listed on the trial.
Crohn's Disease | Microscopic Colitis | Pouchitis | Ulcerative Colitis | C. difficile
Crohn’s Disease
DINE-CD: Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn’s Disease
Aims: To compare the effectiveness of the Specific Carbohydrate Diet and a Mediterranean style diet to induce symptomatic and clinical remission in patients with active Crohn’s disease.
Diagnosis: Crohn’s Disease
Principal Investigator:
IRB Approval Number: EH17-014
Sponsor: University of Pennsylvania Perelman School of Medicine
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes
VEDO-4006: An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy with Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects with Crohn’s Disease Stratified at Higher Risk for Developing Complications
Aims: The primary objective is to determine the effect of triple combination therapy with an anti-integrin(vedolizumab IV), a TNF antagonist (adalimumab SC), and an immunomodulator (oral methotrexate).
Diagnosis: Crohn’s Disease Stratified at Higher Risk for Developing Complications
Principal Investigator:
IRB Approval Number: EH 16-316
Sponsor: Takeda Development Center Americas, Inc.
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes
TRIDENT: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease
Aims: To evaluate the safety and efficacy of the drug in subjects with moderately to severely active Crohn’s disease who have previously failed or who were intolerant to 1 or more approved biologic agents or those who have demonstrated an inadequate response to or have failed to tolerate corticosteroids or immunomodulators.
Diagnosis: Moderately to Severely Active Crohn’s Disease
Principal Investigator:
IRB Approval Number: EH17-003
Sponsor: Janssen Research and Development
Contact: Karina Castro at 847.570.3708
Open to Enrollment: Yes
Microscopic Colitis
Microscopic Colitis Research Registry and Biobank
Aims: The primary objective of the biobank study is to collect clinical information and biological specimens from patients diagnosed with microscopic colitis (including lymphocytic and collagenous colitis), medical history relevant to microscopic colitis diagnosis, and therapies and long term outcomes of patients with microscopic colitis. The biological specimens consist of blood, stool, and tissue samples. This is the first medical registry for patients with microscopic colitis, and we seek to learn more about the natural history of this condition.
Diagnosis: Microscopic colitis, Lymphocytic colitis, and Collagenous colitis
Principal Investigator:
IRB Approval Number: EH16-287
Sponsor: NorthShore University HealthSystem
Contact: Karina Castro at 847.570.3708
Open to Enrollment: Yes
Efficacy and Safety of Oral Rifaximin in Patients with Active Microscopic Colitis
Aims: To evaluate the efficacy of Rifaximin 500mg tid in the induction of clinical remission and histologic response in patients with active microscopic colitis (MC).
Diagnosis: Microscopic colitis, Lymphocytic colitis, and Collagenous colitis
Principal Investigator:
IRB Approval Number: EH17-360
Sponsor: NorthShore University HealthSystem
Contact: Karina Castro at 847.570.3708
Open to Enrollment: Yes
Pouchitis
EARNEST: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis
Aims: To compare the effectiveness of vedolizumab IV compared to placebo in terms of the percentage of subjects achieving remission in subjects with chronic or recurrent pouchitis, after a 14 week treatment period.
Diagnosis: Chronic Pouchitis
Principal Investigator:
IRB Approval Number: EH17-274
Sponsor: Takeda Development Center Americas, Inc.
Contact: Karina Castro at 847.570.3708
Open to Enrollment:Yes
Ulcerative Colitis
ABBVIE: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Aims: The objective of this clinical trial is to characterize the dose response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in subjects with moderately to severely active ulcerative colitis.
Diagnosis: Moderately to Severely Active Ulcerative Colitis
Principal Investigator:
IRB Approval Number: EH17-030
Sponsor: AbbVie Inc. Pharmaceutical Development
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes
ENTERPRET: A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis
Aims: The primary objective of this clinical trial isto determine the effect of vedolizumab IV dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in subjects with UC and high vedolizumab clearance.
Diagnosis: Moderately to Severely Active Ulcerative Colitis
Principal Investigator:
IRB Approval Number: EH17-175
Sponsor: Takeda Development Center Americas, Inc.
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes
LUCENT: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis
Aims: To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC).
Principal Investigator:
IRB Approval Number: EH17-175
Sponsor: Eli Lilly and Company
Contact: Karina Castro at 847.570.3708
Open to Enrollment: Yes
C. difficile
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:
IRB Approval Number: EH18-378
Sponsor: Finch Research and Development LLC
Contact: Iris Chiou at 847.570.2138
Open to Enrollment: Yes