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Clinical Studies
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A Multicenter Randomized, Double-blinded, Placebo-controlled Study of Posaconazole in Genetically-defined Patients with Active Crohn's Disease (PRECISION)
Rochester, Minn.
The purpose of this study is to evaluate the effects of oral antifungal treatment with posaconazole on disease activity and the burden of Malassezia spp. in CD patients with the CARD9 S12N allele. Further, this project will investigate the hypothesis that the microbial changes induced by antifungal treatment are associated with dampened downstream immune responses in those with a genetic predisposition to developing strong immune responses to Malassezia.
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A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders (PROP-RD)
Rochester, Minn.
The primary purpose of this study is to create a prospective registy of patients with pouch-related conditions to allow for longitudinal assesment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis ( CARP or CD of the pouch).
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Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe
Flares: A Phase 3 Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Rochester, Minn.
The purpose of this study is to determine the impact of HBOT (hyperbaric oxygen therapy) on clinical response/remission to medical therapy as measured bycomplete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for biologics, small molecules, or colectomy, by study day 5.
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Mayo Clinic Inflammatory Bowel Disease Repository (Mayo Clinic Inflammatory Bowel Disease Repository)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this research study is to collect clinical information and human samples from patients with IBD. The data collected will be used to create an organized, accessible resource of human samples for biological research in IBD.
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Study of Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC-IBD) (SPARC-IBD)
Rochester, Minn.
The goal of this study is to create a cohort of patients with Inflammatory Bowel Disease (IBD) who have linked clinical data, self-reported outcome data, and biosamples that can be used for clinical and translational research that will lead to medicine strategies and new therapeutic targets that will improve the quality of life of patients with IBD.
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The PROP-RD Study: A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders
Rochester, Minn.
The primary purpose of this study is to create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis (acute pouchitis, CADP, CARP, or CD of the pouch).
Closed for Enrollment
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A Comprehensive Evaluation of Pouch Evacuation Dynamics and Pouchitis
Rochester, Minn.
The purpose of this study is to find out if there is a relationship between pouch function (the ability to completely evacuate or empty the pouch) and the development of inflammation in the pouch.
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A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study (LTE)
Rochester, Minn.
The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
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Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients with Inflammatory Bowel Disease: Part I – The Need
Rochester, Minn.
The purpose of this study assess the current patient practice (standard of care) on Health Related Quality of Life (HRQOL), perceived stress level and disease activity in female patients with Inflammatory Bowel Disease (IBD).
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Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients with Inflammatory Bowel Disease: Phase II – The Impact (IBD and WHC II)
Rochester, Minn.
The purpose of this research study is to assess women who are diagnosed with Inflammatory Bowel Disease (IBD) and study the combination of using usual medical treatment with a wellness program designed just for women with IBD and the effect it has on quality of life, stress, and their symptoms
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Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial
Rochester, Minn.
The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.
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Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Cx601, Allogeneic Expanded Adipose-derived Stem Cells for Complex Perianal Fistula(s) in Crohn's Disease.ADMIRE-CD-II (ADMIRE-CD-II)
Rochester, Minn.
The purpose of this study is to assess the effectiveness and safety of Cx601, 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.
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Prevention of Pouchitis with Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
Rochester, Minn.
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.
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Role of Microbiota in the Pathogenesis of Pouchitis
Rochester, Minn.
The purpose of this study is to learn more about the bacteria that live in the small and large intestine and the role that these bacteria play in causing inflammation in the gastrointestinal tract.
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UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas (UC)
Rochester, Minn.
The purpose of this research is to determine if different diets have different effects on the micribiome and inflammation of your colon.
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