Digestive Health Clinical Research

Clinical Research Studies in Digestive Health

Biliary and Liver Disease

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)
Principal Investigator: Blaire Burman, MD
Status: Closed to Enrollment

 

Clostridioides difficile (C. diff)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY

Principal Investigator: Gautam Mankaney, MD
Status: Enrolling

 

Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

Crohn's Disease: Risankizumab versus Ustekinumab for Subjects with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

 

Diverticulitis

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Principal Investigator: Val Simianu, MD
Status: Enrolling

Familial Adenomatous Polyposis (FAP)

REC-4881-201 A PHASE 2, MULTICENTER, TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REC-4881 IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
Principal Investigator: Gautam Mankaney, MD
Status: Enrolling

Gastroparesis

Examination of Programming with the Enterra® Therapy System in a Double-Blinded, randomized, Prospective Study In the Treatment of Nausea and Vomiting Symptoms using Gastric Electrical Stimulation
Principal Investigator: Pierre Blais, MD 
Status: Enrolling

Non Alcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis due to NASH
Principal Investigator: Asma Siddique, MD
Status: Closed to Enrollment

 

 

Stricture

Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Bowel
Principal Investigator: Joanna Law, MD
Status: Enrolling

 

Ulcerative Colitis

A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults with Mild to Moderate Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Enrolling

Casting Light on Urgency and Effectiveness of Advanced Therapies in Ulcerative Colitis (CLUES-UC): A Non-interventional, Observational Cohort Study of Mirikizumab and Other Biologics in Adult Participants with Moderately to Severely Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Enrolling

 

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment