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Research and Clinical Trials at Atlantic Digestive Health Institute

Our team at Atlantic Digestive Health Institute not only provides excellent medical care, but also remains active in clinical research trials from which our patients may benefit. Our participation in clinical trials has helped expand treatment options for patients dealing with digestive diseases.

Your health care team will discuss all aspects of your diagnosis and treatment options, allowing you to choose from a range of medical and surgical options. We also offer emotional, dietary, integrative medicine and educational services.

We are an IBD center of excellence and have multiple studies covering both Crohn’s Disease and ulcerative colitis.

Short Title

Condition of Interest/ Investigational Product

Full Protocol Title

Status

                                    ADMIRE-CD II / Stem Cell Study (Tigenix / Cx601-0303)

Complex Perianal Fistula(s) in Crohn's Disease/ Darvadstrocel vs. Placebo

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicenter study to assess efficacy and safety of Cx601 (Darvadstrocel), adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. (ADMIRE-CD II Study)

OPEN TO ENROLLMENT

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

Corrona-IBD-600 (Registry)

ALL IBD Patients / Non-Interventional

Corrona Inflammatory Bowel Disease (IBD) Registry

OPEN TO ENROLLMENT

Corrona Inflammatory Bowel Disease (IBD) Registry

FMT Registry

ALL FMT Patients / Non Interventional

Fecal Microbiota Transplant National Registry

OPEN TO ENROLLMENT

Fecal Microbiota Transplant National Registry

GALAXI (CNTO1959CRD3001)

Moderate to Severe Crohn's Disease / 5 Treatment Arms = Placebo vs. High/Middle/Low Dose Guselkumab vs. Stelara

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease (CNTO1959CRD3001)- 5 TREATMENT ARMS

OPEN TO ENROLLMENT

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Proactive PRV-015-002b (AMG 714)

Celiac Disease

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult
Patients with Non-Responsive Celiac Disease as an Adjunct to a
Gluten-free Diet

OPEN TO ENROLLMENT

PRV-015 in Gluten-free Diet Non-responsive Celiac Disease - No Study Results Posted

SERES-013 ECOSPOR

Recurrent C. diff Infection / All patients receive SER-109

ECOSPOR IV: An open-label extension (OLE) of study SERES-012 Evaluating SER-109 in Adult Subjects with Recurrent Clostridium difficle Infection (RCDI)

OPEN TO ENROLLMENT

ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI) | Clinical Research Trial Listing ( Clostridium Difficile Infection | Clostridioides Difficile Infection ) ( NCT03183141 )

Eli Lilly / J1P-MC-KFAH

Ulcerative Colitis / IL-2 Study (Phase 2)

An Adaptive Phase 2, Randomized, Double‑Blind, Placebo‑Controlled Study of LY3471851 (NKTR‑358) in Patients with Moderately to Severely Active Ulcerative Colitis

OPEN TO ENROLLMENT

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)