Current Clinical Trials

Patients are invited to work with us so that together we may refine and improve medical and surgical treatments. Two full-time study coordinators Laura Trachtenberg, MS (pictured right), and Anna Williford, RN, as well as Wendy Kaiser, RN, administer these studies.

Digestive Surgery Research Laboratory

Through the Digestive Surgery Research Laboratory, patients of University of Louisville's Section of Colon & Rectal Surgery have the opportunity to participate in research by enrolling in clinical trials. Below are trials that have been open to patient accrual over the last year, many of which are still ongoing. To learn more about our ongoing studies, please contact our research coordinator Anna Williford, RN, at 502.583.0880 or email her.

"A randomized controlled trial to compare the functional outcome and quality of life of patients with low rectal cancer who undergo a J-Pouch or a side to end coloanal anastomosis."
PI: Galandiuk, S.
(Sponsor: The Cleveland Clinic)

"Protocol C13007/ A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease."
PI: Galandiuk, S.
(Sponsor: Millennium Pharmaceutical, Inc.)

"Protocol C13008/ A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease."
PI: Galandiuk, S.
(Sponsor: Millennium Pharmaceutical, Inc.)

"A 5-Year, Non-Interventional Registry Study of HUMIRA^® (Adalimumab) in Patients with Moderately to Severely Active Crohn’s Disease (CD)."
PI: Galandiuk, S.
(Sponsor: Abbott Pharmaceutical, Inc.)

"Prospective open-label study of a smokeless tobacco product in Crohn's disease patients with moderately to severely active Crohn's disease who have failed prior attempts at smoking cessation."
PI and Sponsor: Galandiuk, S.

"The Association of Gastrointestinal Disease, DNA Repair and Host Defense Genes."
PI and Sponsor: Galandiuk, S.

Surgical Infection Laboratory

The following study is being conducted at the Surgical Infection Laboratory:

"SIS Multicenter Study of Duration of Antibiotics for Intra-abdominal Infection."
PI: Polk HC, Jr.
(Sponsor: SIS)

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