Open Clinical Trials
Inside Stanford Digestive Health - Winter/Spring 2023
Crohn's Disease
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease (NCT03395184)
Jak inhibitors are a family of oral small molecules that modulate the immune response and have efficacy in treating ulcerative colitis. They are now being studied for the treatment of Crohn’s with encouraging data from early clinical trials. This study is under the direction of Dr Sarah Streett.
Stanford Study Coordinator: Adrian Ekelmans
Email: adrian01@stanford.edu
Phone: 650-721-8436
Irritable Bowel Syndrome
Zemedy Application for Irritable Bowel Syndrome NCT04723056
Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.
Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
Learn more: https://clinicaltrials.gov/ct2/show/NCT04723056
Stanford Study Coordinator: Brittany Delain Marsh
Email: brimarsh@stanford.edu
Phone: (650) 725-9321
Non-Alcoholic Steatohepatitis
A Pilot Study to treat adults with Non-Alcoholic Steatohepatitis with oral Idebenone NCT04398134
Nonalcoholic fatty liver disease is the most common liver disease worldwide. Present in approximately 25% of the United States population, these individuals are at risk for progressive liver disease and the development of nonalcoholic steatohepatitis that can lead to progressive fibrosis and cirrhosis. There are no approved therapies for this disease and lifestyle modifications remain the mainstay of therapy. Stanford is currently testing multiple novel agents for the treatment of nonalcoholic steatohepatitis including the novel anti- oxidant agent idebenone. This trial is enrolling individuals with NASH and stage 1-3 fibrosis, as assessed by elastography or liver biopsy. Fibrosis assessment prior to and after treatment for a 48 week duration will be by MR of the liver with elastography, no liver biopsy is required. This study is under the direction of Dr Natalie Torok ntorok@stanford.edu.
Learn more: https://clinicaltrials.gov/ct2/show/NCT04669158
Stanford Study Coordinator: Adrian Ekelmans
Email: adrian01@stanford.edu
Phone: 650-721-8436
Non-alcoholic Steatohepatitis With Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) NCT04321031
Fatty liver disease and NASH are “silent” diseases, which means that my people will be completely unaware of that they are at risk of liver damage. If left untreated, NASH can lead to cirrhosis (scarring of the liver), liver cancer, the need for liver transplantation and even death. Currently there is no medical treatment available for NASH with fibrosis.
The MIRNA study aims to identify people with NASH with liver fibrosis and investigate thepotential benefits of two different study drugs to treat this disease. The study evaluates two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
Learn more: https://clinicaltrials.gov/ct2/show/NCT04321031
For more information, contact Dr. Mindie Nguyen, mindiehn@stanford.edu.
In This Issue
Winter/Spring 2023