Dr. Amit Kulkarni, MD

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University of Minnesota

Studies Psychogenic Colitis
Studies Inflammatory Bowel Disease
2 reported clinical trials
3 drugs studied

Affiliated Hospitals

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University Of Minnesota

Clinical Trials Amit Kulkarni, MD is currently running

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RMT

for Colitis

Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL). Steroids are the first line of treatment for severe ICI induced Immune- mediated diarrhea and colitis (IMDC). If there is no improvement in 48 to 72 hours, other immunosuppressive agents (infliximab, vedolizumab) are recommended. However, efficacy data supporting the use of immunosuppressives for steroid refractory IMDC is limited by case reports/series. Clinical trials focusing on steroid-refractory colitis are sparse. Novel treatments for IMDC outside of blanket immunosuppression are needed. There is robust evidence to suggest that gut microbial diversity and composition is associated with both ICI efficacy and toxicity. Preliminary studies have shown that pathophysiology of immune mediated colitis may be related to loss of gut microbial diversity. Recently, multiple case series have shown the utility of fecal microbiota transplant for treatment of refractory IMDC providing the proof of concept. This is a pilot randomized placebo controlled study to assess the safety and feasibility of oral restorative microbiota therapy (RMT) in patients with steroid- refractory IMDC.

Recruiting

0 awards

Phase 2

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Pembrolizumab

for Early-Stage Non-Small Cell Lung Cancer

A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm. Patients will be randomized (1:1) 4-12 weeks following surgery to either: * Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles * Arm B: Observation Stratification factors will include: PD-L1 TPS (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm)

Recruiting

1 award

Phase 2

5 criteria

More about Amit Kulkarni, MD

Clinical Trial Related

1 year of experience running clinical trials · Led 2 trials as a Principal Investigator · 2 Active Clinical Trials

Treatments Amit Kulkarni, MD has experience with

  • Placebo
  • RMT
  • Pembrolizumab

Breakdown of trials Amit Kulkarni, MD has run

Psychogenic Colitis

Inflammatory Bowel Disease

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