C. Difficile
C. DIFF According to the CDC
Clostridioides difficile (also known as C. diff or CDIFF) is a bacterium that causes diarrhea and colitis (an inflammation of the colon).
It’s estimated to cause almost half a million illnesses in the United States each year.
About 1 in 6 patients who get C. diff will get it again in the subsequent 2-8 weeks.
Within a month of diagnosis, 1 in 11 people over age 65 died of a healthcare-associated C. diff infection.
PRISM-EXT: An Open-Label Extension of CP101 Trial Evaluating Oral FullSpectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection
https://vimeo.com/382604645
Contact Research
Physician Investigator
![Photo of Bharat K Misra M.D.]( "Photo of Bharat K Misra M.D.")
Gastroenterologist and Research Director
Encore Borland Groover Clinical Research (EBGCR)
Clinical Research Location 4800 Belfort Road Jacksonville FL 32256
Contact Research: 9046800871
Research Email: BMisra@encoredocs.com
Notes
Postgraduate Education
1987 – 1988
Rotating Internship
Gandhi Hospital and affiliated hospitals 1989
Resident Physician, Internal Medicine
Nizams Institute of Medical Sciences 1990 – 1992
Residency, Internal Medicine
Nassau County Medical Center, State University of New York at Stony Brook 1992 – 1993
Chief Residency, Department of Medicine
Nassau County Medical Center, State University of New York at Stony Brook 1993 – 1995
Fellowship, Gastroenterology
Nassau County Medical Center, State University of New York at Stony Brook
RESEARCH TRAINING:
03/01/2018 CITI Good Clinical Practice Course [exp. 2/2021]
05/10/2017 TransCelerate ICH GCP
03/25/2016 iMedidata Rave EDC Training
04/27/2015 TransCelerate ICH GCP
Henn MR, O’Brien EJ, Diao L, et al. A phase 1b safety study of SER-287, a spore-based microbiome therapeutic, for active mild to moderate ulcerative colitis. Gastroenterology. 2021;160(1):115-127.e30.
The Role of a Primary Care Physician in the Management of Inflammatory Bowel Disease. “Northeast Florida Medicine”, 2016.
Author of Chapter on Gastrointestinal Bleeding in the Manual of Critical Care Medicine, a multi author textbook published by the American College of Physicians (ACP)
ABSTRACTS
CP101, an Investigational Orally Administered Microbiome Therapeutic was Effective for Prevention of Recurrent C. difficile Infection: Results from Open-Label PRISM-EXT Trial. DDW May 2022
CP101, an Investigational Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection: A Combined Analysis of the PRISM3 (randomized placebo-controlled) and PRISM-EXT (open-label extension) trials. DDW May 2022
CP101, an Investigational Orally Administered Microbiome Therapeutic, Increases Intestinal Microbiome Diversity and Prevents Recurrent C. difficile Infection: Results from a Randomized, Placebo-Controlled Trial. ACG 2021
Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection. ACG 2021
CP101 Engraftment Drives Efficacy: Results from a Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for Prevention of Recurrent C. difficile Infection. ACG 2021
SERES-101: A multiple dose phase 1b study to evaluate the efficacy, safety and microbiome dynamics of Seres-287 in subjects with mild-to-moderate Ulcerative Colitis (UC). ACG 2021
A multiple dose phase 1b study to evaluate the efficacy, safety and microbiome dynamics of Seres-287 in subjects with mild-to-moderate Ulcerative Colitis (UC). Abstract and Oral presentation at Digestive Diseases Week in Washington D.C. June 2018
Evaluation of health related quality of life in patients treated with RBX2660 (microbiota suspension) for recurrent C. difficile infection. Bharat K. Misra, M.D., Mayur S. Ramesh, MD, Mary Kay Sobcinski, RN, MHA. Borland Groover, Jacksonville FL; Henry Ford Health System, Detroit, MI; Rebiotix Inc., Roseville MN. ACG Philadelphia, Oct 2014
RBX2660 (microbiota suspension) for recurrent C difficile infection: 60 day interim analysis of the PUNCH CD phase 2 safety study. Mayur S Ramesh, MD, Bharat Misra, MD, Arnab Ray, MD, Robert Smith, MD, Mary Kay Sobcinski, RN,MHA
Henry Ford Hospital System, Detroit, MI; Borland Groover, Jacksonville FL; Ochsner Clinic, New Orleans, LA; Rebiotix Inc., Roseville MN. Philadelphia, Oct 2014
Budd-Chiari syndrome secondary to inferior venacava thrombosis in the setting of HIV Disease and Protein C deficiency: Bharat K. Misra, M.D. Abstract and poster, American College of Physicians, New York, NY.
Endoscopic treatment of Symptomatic Intraluminal migrated Marlex mesh in banded Roux-n-Y Gastric Bypass. H. Yasrebi, B.K. Misra. Abstract and Poster presentation at the American Society for Metabolic and Bariatric Surgery (ASMBS) meeting, Washington D.C. June 2009.
Notes
1987 – 1988
Rotating Internship
Gandhi Hospital and affiliated hospitals 1989
Resident Physician, Internal Medicine
Nizams Institute of Medical Sciences 1990 – 1992
Residency, Internal Medicine
Nassau County Medical Center, State University of New York at Stony Brook 1992 – 1993
Chief Residency, Department of Medicine
Nassau County Medical Center, State University of New York at Stony Brook 1993 – 1995
Fellowship, Gastroenterology
Nassau County Medical Center, State University of New York at Stony Brook
RESEARCH TRAINING:
03/01/2018 CITI Good Clinical Practice Course [exp. 2/2021]
05/10/2017 TransCelerate ICH GCP
03/25/2016 iMedidata Rave EDC Training
04/27/2015 TransCelerate ICH GCP
Henn MR, O’Brien EJ, Diao L, et al. A phase 1b safety study of SER-287, a spore-based microbiome therapeutic, for active mild to moderate ulcerative colitis. Gastroenterology. 2021;160(1):115-127.e30.
The Role of a Primary Care Physician in the Management of Inflammatory Bowel Disease. “Northeast Florida Medicine”, 2016.
Author of Chapter on Gastrointestinal Bleeding in the Manual of Critical Care Medicine, a multi author textbook published by the American College of Physicians (ACP)
ABSTRACTS
CP101, an Investigational Orally Administered Microbiome Therapeutic was Effective for Prevention of Recurrent C. difficile Infection: Results from Open-Label PRISM-EXT Trial. DDW May 2022
CP101, an Investigational Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection: A Combined Analysis of the PRISM3 (randomized placebo-controlled) and PRISM-EXT (open-label extension) trials. DDW May 2022
CP101, an Investigational Orally Administered Microbiome Therapeutic, Increases Intestinal Microbiome Diversity and Prevents Recurrent C. difficile Infection: Results from a Randomized, Placebo-Controlled Trial. ACG 2021
Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection. ACG 2021
CP101 Engraftment Drives Efficacy: Results from a Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for Prevention of Recurrent C. difficile Infection. ACG 2021
SERES-101: A multiple dose phase 1b study to evaluate the efficacy, safety and microbiome dynamics of Seres-287 in subjects with mild-to-moderate Ulcerative Colitis (UC). ACG 2021
A multiple dose phase 1b study to evaluate the efficacy, safety and microbiome dynamics of Seres-287 in subjects with mild-to-moderate Ulcerative Colitis (UC). Abstract and Oral presentation at Digestive Diseases Week in Washington D.C. June 2018
Evaluation of health related quality of life in patients treated with RBX2660 (microbiota suspension) for recurrent C. difficile infection. Bharat K. Misra, M.D., Mayur S. Ramesh, MD, Mary Kay Sobcinski, RN, MHA. Borland Groover, Jacksonville FL; Henry Ford Health System, Detroit, MI; Rebiotix Inc., Roseville MN. ACG Philadelphia, Oct 2014
RBX2660 (microbiota suspension) for recurrent C difficile infection: 60 day interim analysis of the PUNCH CD phase 2 safety study. Mayur S Ramesh, MD, Bharat Misra, MD, Arnab Ray, MD, Robert Smith, MD, Mary Kay Sobcinski, RN,MHA
Henry Ford Hospital System, Detroit, MI; Borland Groover, Jacksonville FL; Ochsner Clinic, New Orleans, LA; Rebiotix Inc., Roseville MN. Philadelphia, Oct 2014
Budd-Chiari syndrome secondary to inferior venacava thrombosis in the setting of HIV Disease and Protein C deficiency: Bharat K. Misra, M.D. Abstract and poster, American College of Physicians, New York, NY.
Endoscopic treatment of Symptomatic Intraluminal migrated Marlex mesh in banded Roux-n-Y Gastric Bypass. H. Yasrebi, B.K. Misra. Abstract and Poster presentation at the American Society for Metabolic and Bariatric Surgery (ASMBS) meeting, Washington D.C. June 2009.