Dr. Josh Korzenik, director of the Brigham and Women’s Crohn’s and Colitis Center, and his team are conducting a new research study called the SHIP Study. This study is a clinical trial being done to investigate the efficacy of a drug called sulfasalazine as a treatment in patients with primary sclerosing cholangitis. Dr. Korzenik is looking to enroll patients with PSC who may report abnormally high ALP results and have no known sulfa allergy. Upon initial interest, potential participants will be given a thorough description of the study and be asked to sign a consent form. Further lab tests may be done to ensure eligibility. Participation in this study will take from 14 to 18 weeks long, with the opportunity to continue taking the drug open-label after the initial study period is over, and will require participants to attend 7 study visits, all of which can be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn for a few lab tests throughout the study. For further questions and interest in the study, please call 857-288-8358 or reach out via email at PSCResearch@BWH.HARVARD.EDU.
Hydroxocobalamin Trials
We believe that a fundamental driver of disease in IBD and PSC is the excessive production of bacterially produced H2S and/or reduced detoxification of H2S linked to the production of NO. A series of four clinical trials are being conducted to evaluate the use of hydroxocobalamin, a form of Vitamin B12, as a scavenger for excess H2S, and treatment for patients with ulcerative colitis, pouchitis, and primary sclerosing cholangitis. If you are interested in the hydroxocobalamin trials and would like more information on how you may qualify, please call 857-288-8358 or reach out via email at PSCResearch@BWH.HARVARD.EDU.
SHrIMp: A Study on Hydroxocobalamin Given Orally and Intramuscularly to Healthy Populations
Before we do clinical trials, we want to make sure that hydroxocobalamin doesn’t cause too much pain at the injection site, or cause diarrhea. This SHrIMp study will test 10 healthy people taking an oral form of hydroxocobalamin before we move onto patients with UC, pouchitis, or PSC.
DoLPHin: Detoxification of the Liver in PSC Patients using Hydroxocobalamin
The DoLPHin study will investigate the efficacy of hydroxocobalamin as a treatment in patients with primary sclerosing cholangitis. Dr. Korzenik is looking to enroll adults with PSC who may report abnormally high ALP results. Upon initial interest, potential participants will be given a thorough description of the study and be asked to sign a consent form. Further lab tests may be done to ensure eligibility. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. We will be working with about 5 sites on this project, but a research nurse can visit the participant in-home for the convenience of the participant if the participant cannot reach a site themselves.
HARBOUR: Hydroxocobalamin Approach to Remission with Butyrate for Ulcerative Colitis Research
The HARBOUR study will investigate the efficacy of hydroxocobalamin as a treatment in patients with ulcerative colitis. Dr. Korzenik is looking to enroll about 34 adults with UC. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation will also involve receiving butyrate daily. The study will require participants to attend 7 study visits, and participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. A flexible sigmoidoscopy will be performed at screening and week 4 for all individuals as well. This will be a multicenter study.
Pelican: Hydroxocobalamin in Patients with Pouchitis
The Pelican study will investigate the efficacy of hydroxocobalamin as a treatment in patients with pouchitis. Dr. Korzenik is looking to enroll about 12 adults with pouchitis for a quick, open-labeled 4-week cohort study. Participation will take the study drug for 4 weeks in the form of an oral medication taken twice daily, and the study will require participants to attend 5 study visits, track the medication in a log, and get blood drawn and give a stool sample for a few lab tests throughout the study. A flexible sigmoidoscopy will be performed at screening and week 4 for all individuals as well. This study will be conducted solely at BWH.
Biorepositories and observational studies
PSC Registry
Much research remains to be done on the causes of PSC and how we can more effectively treat it. The rarity of the disease typically impedes researchers from identifying eligible subjects for a study and having access to patient samples. In collaboration with Dan Pratt, MD, from Massachusetts General Hospital, we've established a PSC data registry and biobank in an effort to accelerate research efforts into the disease.
This database is focused on gathering as much information on patients as possible to eventually facilitate research in this area. In addition, the tissue collected and stored in the repository will provide future researchers with material to study. As the samples will be stored for as yet undefined uses, the types of research expected are genetic, proteomic, and metabolomic analyses.
