Clinical Studies
Luminal
RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn s disease: The OPTIMIZE Trial
Prinicpal Investigator: Byron Vaughn
Currently Recruiting
Description: The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.
Corrona Inflammatory Bowel Disease (IBD) Registry
Prinicpal Investigator: Byron Vaughn
Currently Recruiting
Description: This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
The women with inflammatory Bowel Disease and Motherhood: A Prospective Registry
Principal Investigator: Eugenia Shmidt
Currently Recruiting
Description: This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.
Microbiota Therapeutics Program
The Microbiota Therapeutics Program is active in actively recruiting patients for clinical trials related to Leukemia, Ulcerative Colitis, and more. Go to the UMN Microbiota Therapeutics Program website for more information.
The gut microbiome and T cells in celiac disease
Principal Investigator: Alexa Weingarden
Currently Recruiting
Description: In celiac disease, T cells that recognize proteins from wheat, barley, and rye (gluten) cause inflammation in the gut. However, we don't understand what triggers this inflammation. In this study, we are trying to understand if differences in intestinal bacteria correspond to differences in these T cells in healthy individuals compared to those with celiac disease. This is a non-interventional study where we are collecting duodenal fluid (aspirates), duodenal biopsies, blood, and fecal samples to track these differences.
Contact us: [email protected]
A novel partial-enteral nutrition protocol to improve nutrition status of adult patients experiencing a Crohn's disease flare and starting new immunologic therapy
Principal Investigator: Byron Vaughn
Currently Recruiting
Description: The purpose of this study is to evaluate if a partial enteral nutrition diet, with a pea protein plant-based oral nutrition supplement (ONS; Kate Farms Peptide 1.5), combined with the Inflammatory bowel disease - Anti-Inflammatory Diet (IBD-AID) improves the nutritional intake of adult patients experiencing a CD flare initiating immunologic therapy compared to standard of care. Standard of care for patients experiencing a CD flare is commonly characterized by prescription of a low fiber diet and either lack of oral nutrition supplementation or use of an animal protein based supplement.
Contact us: [email protected]
Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial
Principal Investigator: Byron Vaughn
Currently Recruiting
Description: The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.
Inflammatory Bowel Disease (IBD) Registry
Principal Investigator: Byron Vaughn
Currently Recruiting
Description: This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
Contact us: [email protected]
Standardized Microbiota Transplant Therapy in Crohn's Disease
Principal Investigator: Byron Vaughn
Currently Recruiting
Description: Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.
Hepatology
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
Principal Investigator: Elizabeth Aby
Currently Recruiting
Description: This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). PSC patients will receive an antibiotic preconditioning regimen of oral vancomycin and oral amoxicillin for 7 days Following vancomycin and amoxicillin, encapsulated, freeze-dried microbiota preparation for a total of 14 days. Patients will provide labs, stool samples, and undergo fibroscan + colonoscopy before and after study intervention.
National Liver Cancer Screening Trial (TRACER)
Principal Investigator: Elizabeth Aby
Currently Recruiting
Description: The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection.
Eligible patients (between 18 and 85 years of age) will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Patients will be recruited over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.
Phase-I clinical trial to evaluate the safety of miroliverELAP in adult patients with acute liver failure.
Principal Investigator: Thomas Leventhal
Currently Recruiting
Description: MiroliverELAP system is a combination product consisting of a single-use external bioengineered liver and a blood pump. The bioengineered liver is made from a porcine (pig) liver that has all of the porcine cells removed. This liver structure is then seeded with human liver cells from a donor. There are no animal cells in the bioengineered liver. The bioengineered liver is intended to support liver function by metabolizing ammonia and reducing other systemic toxins. The therapy works by pumping blood from the patient through the bioengineered liver and then returning the blood back to the patient. In simple terms, this study therapy is intended to function as temporary dialysis for the liver.
StudyFinder is a University of Minnesota website that displays a searchable listing of studies, which are extracted from ClinicalTrials.gov. At StudyFinder you can explore University health studies currently seeking participants.
Clinicaltrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
CONTACT US
If you're interested in getting involved in our studies or would like to collaborate, please reach us via email: [email protected]