Bharat Misra, MD |Gastroenterologist

• American Board of Internal Medicine, 1993
• American Board of Internal Medicine, Gastroenterology, 1995, 2005, 2016, 2025
• Basic Life Support and Advanced Cardiac Life Support, Current, renewed every 2 years

Florida

Publications:

Clinical Validation of a Circulating Tumor DNA–Based Blood Test to Screen for Colorectal Cancer. Aasma Shaukat, MD, MPH1,2; Carol A. Burke, MD3; Andrew T. Chan, MD, et.al. 2025;334;(1):56-63. doi:10.1001/jama.2025.7515

Artificial Intelligence for Real-Time Prediction of the Histology of Colorectal Polyps by General Endoscopists. Ann Intern Med. Rex DK, Bhavsar-Burke I, Buckles D, Burton J, Cartee A, Comar K, Edwards A, Fennimore B, Fischer M, Gerich M, Gilmore A, Hamdeh S, Hoffman J, Ibach M, Jackson M, James-Stevenson T, Kaltenbach T, Kaplan J, Kapur S, Kohm D, Kriss M, Kundumadam S, Kyanam Kabir Baig KR, Menard-Katcher P, Kraft C, Langworthy J, Misra B, Molloy E, Munoz JC, Norvell J, Nowak T, Obaitan I, Patel S, Patel M, Peter S, Reid BM, Rogers N, Ross J, Ryan J, Sagi S, Saito A, Samo S, Sarkis F, Scott FI, Siwiec R, Sullivan S, Wieland A, Zhang J, Repici A, Hassan C, Byrne MF, Rastogi A. 2024 Jul;177(7):911-918. doi: 10.7326/M24-0086. Epub 2024 May 21. PMID: 38768450.

Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial. Jessica R Allegretti 1, Colleen R Kelly 2, Thomas Louie 3, Monika Fischer 4, Susy Hota 5, Bharat Misra 6, Nick W Van Hise 7, Eugene Yen 8, Jeffrey S Bullock 9, Michael Silverman 10, Ian Davis 11, Sarah K McGill 12, Darrell S Pardi 13, Robert Orenstein 14, Ari Grinspan 15, Najwa El-Nachef 16, Paul Feuerstadt 17, Thomas J Borody 18, Sahil Khanna 13, Shrish Budree 19, Zain Kassam 20 Gastroenterology, Volume 168, Issue 2, 357 – 366.e3

Prevalence of Comorbid Factors in Patients with Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota–Based Therapeutic. Charles S Berenson et al. Clin Infect Dis 2023

Desai K, Gupta S, May FP, Xu G, Shaukat A, Hommes DW, NICE-AA/CRC- Consortium, Early detection of advanced adenomas and colorectal carcinoma by serum glycoproteome profiling., Gastroenterology 2023;166:194-197

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.

MisraB, Gastrointestinal Bleeding. Raoof, George, Saleh, Sung. Manual of Critical Care. McGraw-Hill 2009,634-639. Author of Chapter in the Manual of Critical Care Medicine, a multi- author textbook published by the American College of Physicians (ACP).

Abstracts:

Rheumatoid Vasculitis: An Unusual Cause of Abdominal Pain in an Older Patient. ACG Oct 2023

Patients Prefer Blood based Screening Tests Compared with Current Options for Colorectal Cancer Screening in a Community Based Confidential Survey. ACG Oct 2022

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. ACG Philadelphia, Oct 2014

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.

Budd-Chiari syndrome secondary to inferior vena cava 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.

Clinical Research:

Principal Investigator:

1. ALPCO Calprotectin Assay
   Protocol Title: “Evaluation of the Calprotectin Immunoturbidimetric Assay for the Diagnosis of Inflammatory Bowel Disease”
   ClinicalTrials.gov NCT07089420
2. Vedanta Biosciences — VE303 (RESTORATiVE303)
   Protocol Title: “A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides difficile Infection (RESTORATiVE303)”
   Vedanta Biosciences
3. Phathom Pharmaceuticals — NERD-302 (GERD)
   Protocol Title: “A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg and 20 mg Compared to Placebo for Relief of Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)”
   ClinicalTrials.gov NCT05195528
4. Ferring Pharmaceuticals — 000417 (Ulcerative Colitis)
   Protocol Title: “A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, in Adults with Mild to Moderate Ulcerative Colitis”
   PubMed PMID: 32763240
5. AstraZeneca — D7000C00001 (SUPERNOVA)
   Protocol Title: “Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA)”
   AstraZeneca
6. Eli Lilly — I6T-MC-AMBZ (Ulcerative Colitis)
   Protocol Title: “A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis”
   EudraCT 2017-004092-31
7. Series Therapeutics — RDP001 (Ulcerative Colitis)
   Protocol Title: “A Phase 1b Proof-of-Concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults with Mild to Moderate Ulcerative Colitis”
   Veeva Systems
8. Chugai Pharmaceutical — DQB101US (Celiac Disease)
   Protocol Title: “A Study of the Safety, Pharmacokinetics, Immunogenicity, and Biological Effects of DONQ52 in Celiac Disease Patients with Gluten Challenge”
   Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624000308751
9. InterVenn — INTE-NICE-001 (CRC Screening Blood Test)
   Protocol Title: “A Study to Evaluate the Efficacy and Safety of InterVenn’ s Multi-Cancer Early Detection Blood Test”
   ClinicalTrials.gov NCT04844606
10. Freenome — FRNM-005 (CRC Screening Blood Test)
    Protocol Title: “A Study to Evaluate the Efficacy and Safety of Freenome’ s Multi-Cancer Early Detection Blood Test”
    ClinicalTrials.gov NCT04844606
11. Finch Therapeutics — CDI-301 (Recurrent C. difficile)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of CP101 in Patients with Recurrent Clostridioides difficile Infection”
    ClinicalTrials.gov NCT02618187
12. Phathom Pharmaceuticals — NERD-301 (Non-Erosive GERD)
    Protocol Title: “A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg and 20 mg Compared to Placebo for Relief of Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)”
    ClinicalTrials.gov NCT05195528
13. Freenome — FRNM-004 (PREEMPT, CRC Screening)
    Protocol Title: “A Study to Evaluate the Efficacy and Safety of Freenome’ s Multi-Cancer Early Detection Blood Test”
    ClinicalTrials.gov NCT04844606
14. Phathom Pharmaceuticals — NERD-201 (Non-Erosive GERD)
    Protocol Title: “A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease”
    ClinicalTrials.gov NCT04799158
15. Phathom Pharmaceuticals — HP-301 (Helicobacter pylori)
    Protocol Title: “A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Oral Vonoprazan Dual and Triple Therapy Versus Lansoprazole Triple Therapy in Subjects with Helicobacter pylori Infection”
    ClinicalTrials.gov NCT04124926
16. Phathom Pharmaceuticals — EE-301 (Erosive Esophagitis)
    Protocol Title: “Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis”
    ClinicalTrials.gov NCT04124926
17. Finch Therapeutics — CP101-CDI-E02 (PRISM Extension)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of CP101 in Patients with Recurrent Clostridioides difficile Infection”
    ClinicalTrials.gov NCT02618187
18. Seres Therapeutics — SER-201 (Ulcerative Colitis)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-201 in Patients with Ulcerative Colitis”
    ClinicalTrials.gov NCT02618187
19. Seres Therapeutics — SER-013 (Recurrent C. difficile)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-013 in Patients with Recurrent Clostridioides difficile Infection”
    ClinicalTrials.gov NCT02618187
20. Finch / Crestovo — CDI-001 (Recurrent C. difficile)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of CP101 in Patients with Recurrent Clostridioides difficile Infection”
    ClinicalTrials.gov NCT02618187
21. Seres Therapeutics — SER-012 (Recurrent C. difficile)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-012 in Patients with Recurrent Clostridioides difficile Infection”
    ClinicalTrials.gov NCT02618187
22. Synergy Pharmaceuticals — SP304203-05 (IBS-C)
    Protocol Title: “A Phase 3 Study to Evaluate the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation”
    ClinicalTrials.gov NCT02522767
23. Seres Therapeutics — SER-301 (Ulcerative Colitis)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-301 in Patients with Ulcerative Colitis”
    ClinicalTrials.gov NCT02618187
24. Seres Therapeutics — SER-201 (Ulcerative Colitis)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-201 in Patients with Ulcerative Colitis”
    ClinicalTrials.gov NCT02618187
25. Seres Therapeutics — SER-301 (Ulcerative Colitis)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-301 in Patients with Ulcerative Colitis”
    ClinicalTrials.gov NCT02618187
26. Seres Therapeutics — SER-201 (Ulcerative Colitis)
    Protocol Title: “A Phase 2 Study to Evaluate the Safety and Efficacy of SER-201 in Patients with Ulcerative Colitis”
    ClinicalTrials.gov NCT02618187

Sub-Investigator:

1. “ALTUS: A Multicenter, Prospective Cohort Study to Evaluate the Accuracy and Safety of a Novel Diagnostic Intervention in Patients with Hepatocellular Carcinoma” (Protocol 2021-01 ALTUS, Exact Science, 2024–Present)
2. “ENLIGHTEN-Fibrosis: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis and Fibrosis” (Protocol BIO89-100-131, 89bio, 2024–Present)
3. “SYMMETRY and HARMONY Studies: Phase 2b Proof-of-Concept Trials Evaluating Efruxifermin in Adults with Nonalcoholic Steatohepatitis” (Protocols AK-US-001-0105 and AK-US-001-0107, Akero Therapeutics, 2023–Present)
4. “REMODEL: A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Leronlimab in Participants with Eosinophilic Esophagitis” (Protocol LPS17558, Sanofi, 2023–Present)
5. “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Dupilumab in Eosinophilic Gastroenteritis” (Protocol R668-EGE-2213, Regeneron Pharmaceuticals, 2023–Present)
6. “COSMOS: Study of Investigational Therapy AZD6976 in Patients with Nonalcoholic Steatohepatitis” (Protocol D6581C00001, AstraZeneca, 2023–2024)
7. “CROSSING: Phase 3 Study to Evaluate the Safety and Efficacy of Medications in Patients with Eosinophilic Esophagitis” (Protocol D5244C00001, AstraZeneca, 2023–Present)
8. “CDX0159-08: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Barzolvolimab in Patients with Eosinophilic Esophagitis” (Celldex Therapeutics, 2022–2024)
9. “AK002-027: A Phase 2 Study Evaluating Lirentelimab for Chronic Urticaria” (Allakos, 2022–2023)
10. “PATENT-B: A Prospective Study to Evaluate Efficacy and Safety of a Patented Endoscopic Procedure for Bowel Strictures” (GIE, 2022–Present)
11. “PATENT-E: Prospective Study for Evaluating Endoscopic Therapy for Esophageal Strictures” (GIE, 2022–Present)
12. “HEPA-CRV431-207: A Phase 2 Trial of CRV431 in Adults with Nonalcoholic Steatohepatitis” (Hepion Pharmaceuticals, 2022–2024)
13. “GS-US-454-6075: A Phase 2/3 Study Evaluating the Safety and Efficacy of Gilead Sciences’ Therapy in Subjects with NASH” (Gilead Sciences, 2022–Present)
14. “K-001-201: Phase 2 Clinical Trial to Assess Safety and Efficacy of Kowa’s Investigational Therapy for Nonalcoholic Steatohepatitis” (Kowa Pharmaceuticals, 2022–Present)
15. “AK002-018: Phase 2 Study of Lirentelimab in Patients with Atopic Dermatitis” (Allakos, 2022–2024)
16. “RNLC3131: Study to Evaluate Safety and Efficacy of Salix’s Injectable for Decompensated Hepatic Encephalopathy” (Salix Pharmaceuticals, 2022–Present)
17. “AXA1125-101: A Phase 1 Study Evaluating AXA1125 in Patients with Non-Cirrhotic NASH and Fibrosis” (Axcella Health, 2022)
18. “CC-93538-EE-002: A Phase 2 Study Evaluating Celgene’s CC-93538 in Adults with Eosinophilic Esophagitis” (Celgene, 2022–Present)
19. “TENEO: Evaluation of the Diagnostic Performance of EXACT Sciences Molecular Assay for Liver Cancer Detection” (Exact Science, 2022)
20. “OCA 2019-GI-03: Clinical Trial Assessing AI Colorectal Polyp Detection System” (Olympus, 2021–2023)
21. “AK002-023: Phase 2 Clinical Trial of Lirentelimab for Eosinophilic Gastritis and/or Eosinophilic Duodenitis” (Allakos, 2021–2022)
22. “ALN-HSD-001: Double-Blind, Placebo-Controlled Study of Alnylam’s RNAi Therapeutic in NASH” (Alnylam Pharmaceuticals, 2021–2022)
23. “GFT505B-319-1: Genfit’ s Phase 3 Trial for Elafibranor in Primary Biliary Cholangitis” (Genfit, 2021–Present)
24. “AK002-021: Phase 2 Study of Lirentelimab in Eosinophilic Duodenitis” (Allakos, 2021–2023)
25. “CC-93538-EE-001: Clinical Assessment of Celgene’s Antibody Therapy for Eosinophilic Esophagitis” (Celgene, 2021–Present)
26. “APD334-202: Phase 2 Clinical Trial Evaluating Etrasimod in Crohn’s Disease” (Arena Pharmaceuticals, 2021–2023)
27. “MET642-201: Evaluation of Mepacrine’s Candidate MET642 in NASH” (Metacrine, 2020–2022)
28. “AK002-016X: Open-Label Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Gastroenteritis” (Allakos, 2020–2023)
29. “NG101-201: Neurogastrx’s Phase 2 Study in Gastroparesis” (Neurogastrx, 2020–2022)
30. “EG-CL-102: Lucid Diagnostics Phase 2 Clinical Trial for Adenocarcinoma” (Lucid, 2020–2021)
31. “EG-CL-101: Lucid Diagnostics Phase 2 Evaluation for Barrett’s Esophagus” (Lucid, 2020–2021)
32. “SHP647-303: Phase 3 Clinical Trial for Severe Ulcerative Colitis” (Shire, 2020–2021)
33. “EDP305-102: Enanta Pharmaceuticals Phase 2 Trial in NASH” (Enanta, 2020–Present)
34. “AK002-014: Study of Lirentelimab in Patients with Eosinophilic Esophagitis” (Allakos, 2020–2023)
35. “AK002-016: Phase 2 Evaluation of Lirentelimab in Eosinophilic Gastritis and/or Gastroenteritis” (Allakos, 2020–2022)
36. “AK002-019: Lirentelimab for Eosinophilic Gastrointestinal Diseases” (Allakos, 2020)
37. “M14-234, M14-533, M14-675, M14-430, M14-431, M14-433: A Series of Phase 3 Trials Assessing AbbVie’s Therapies in Ulcerative Colitis and Crohn’s Disease” (AbbVie, 2020–2024)
38. “BLI4900-302: Phase 2 Clinical Trial for Oral Colon Preparation” (Braintree Laboratories, 2019–2021)
39. “SP-1011-003: Adare Pharmaceuticals’ Phase 3 Study Evaluating Therapy for Eosinophilic Esophagitis” (Adare, 2019–2023)
40. “C1061011: Pfizer’s Phase 2 Study for Treatment of Nonalcoholic Fatty Liver Disease” (Pfizer, 2019)
41. “747-304: Intercept Pharmaceuticals’ Phase 3 Trial for Ocaliva (Obeticholic Acid) in NASH” (Intercept Pharmaceuticals, 2018)
42. “COVSBCC0549 “BLINK”: Medtronic’s Gastric Electrical Stimulation Clinical Trial in Gastroparesis” (Medtronic, 2017)
43. “SHP647-302: Phase 3 Trial of Mongersen in Ulcerative Colitis” (Shire, 2017–2020)
44. “C1171002: Pfizer’s Phase 2 Study Investigating Therapy for NASH” (Pfizer, 2017)
45. “MO6-808: Abbott Laboratories’ Study of Adalimumab’s Long-Term Efficacy in Crohn’s Disease” (Abbott, 2007)
46. “RFIB2001: Randomized, Double-Blind, Placebo-Controlled Study of Rifaximin for Irritable Bowel Syndrome with Diarrhea” (Salix Pharmaceuticals, 2007)
47. “ALTL1251/038/CL, ALTL1251/052/CL: Multiple Phase II and III Trials of Alizyme’s Therapy for Irritable Bowel Syndrome with Constipation” (Alizyme, 2005)