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CME / ABIM MOC / CE

Could Viruses Be the New Artillery Against Inflammatory Bowel Disease?

  • Authors: News Author: Maya Davis; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 10/21/2022
  • Valid for credit through: 10/21/2023
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  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    Nurses - 0.25 ANCC Contact Hour(s) (0 contact hours are in the area of pharmacology)

    Physician Assistant - 0.25 AAPA hour(s) of Category I credit

    IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for gastroenterologists, family medicine and primary care clinicians, internists, nurses, physician assistants, and other members of the health care team for patients with inflammatory bowel disease.

The goal of this activity is for learners to be better able to describe a potential treatment targeting inflammation-causing gut bacteria contributing to inflammatory bowel disease by using bacteriophage viruses that may become the basis for developing therapies for inflammatory bowel disease and other types of disorders.

Upon completion of this activity, participants will:

  • Assess a potential treatment targeting inflammation-causing gut bacteria contributing to inflammatory bowel disease by using bacteriophage viruses, based on a study in vitro, in a mouse model, and in human volunteers
  • Evaluate clinical implications of a potential treatment targeting inflammation-causing gut bacteria contributing to inflammatory bowel disease by using bacteriophage viruses, based on a study in vitro, in a mouse model, and in human volunteers
  • Outline implications for the healthcare team


Disclosures

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News Author

  • Maya Davis

    Freelance writer, Medscape

    Disclosures

    Maya Davis has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has the following relevant financial relationships:
    Formerly owned stocks in: AbbVie

Compliance Reviewer/Nurse Planner

  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

Compliance Reviewer

  • Yaisanet Oyola, MD

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Yaisanet Oyola, MD, has no relevant financial relationships.

Peer Reviewer:

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


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CME / ABIM MOC / CE

Could Viruses Be the New Artillery Against Inflammatory Bowel Disease?

Authors: News Author: Maya Davis; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 10/21/2022

Valid for credit through: 10/21/2023

processing....

Clinical Context

Inflammatory bowel diseases (IBDs), including ulcerative colitis (UC) and Crohn's disease (CD), are auto-inflammatory disorders in which an uncontrolled innate and adaptive immune response causes sustained tissue damage. Through multiple mechanisms, the gut microbiota contribute to this aberrant immune response in patients genetically vulnerable to IBD.

Bacteriophages are ubiquitous, self-replicating viruses that infect bacteria with high host specificity. Systemic use of phage therapy is promising as a rescue treatment directed against multidrug-resistant (MDR) pathogens but is limited to short-term use, given bacterial resistance and host immunity. Long-term use of oral phage therapy to sustain suppression of pathological gastrointestinal bacteria is still elusive.

Study Synopsis and Perspective

New research from the ​​Weizmann Institute of Science has shown that bacteriophages, or viruses that infect bacteria cells, can be used to target gut bacteria that worsen symptoms of UC and CD.

The project, published in Cell, studied 537 volunteers in France, Israel, the United States, and Germany to identify the bacteria strains behind the problem-causing inflammation that patients with IBD have.

From stool samples, the scientists identified Klebsiella pneumoniae (Kp) as "strongly associated with [IBD] exacerbation and severity," and filtered through 41 Kp-fighting viruses (called phages), ultimately selecting 5 phages that best targeted the strain and prevented the rise of mutants that could spread resistance.

The "5-phage cocktail" got rid of Kp in lab dishes and reduced inflammation and tissue damage caused by the strain in mice. The phages also proved stable in a fake human gut and were "well-tolerated" when given by mouth in a first-in-human phase I clinical trial of 18 healthy volunteers. In the trial, the phages multiplied in the intestines and caused no off-target changes, according to the researchers.

"To our knowledge, this constitutes the first 'silver bullet' approach promising a precise suppression of disease-causing gut microbes, without harming the surrounding microbiome," said Eran Elinav, PhD, the lead author and a professor in Weizmann's Systems Immunology Department.

The work shows that it is possible to manage IBD with something other than antibiotics, which are less specific, can cause adverse effects, and likely trigger bacterial resistance, the researchers said. They stressed the resistance-avoiding qualities of phages given by mouth and hope that the phage therapy will one day be used with induction therapy in IBD, according to the study.

"If the phage cocktail is found to be safe and effective in larger clinical trials, it may become the basis for developing therapies for not only inflammatory bowel disease but also other disorders found to be affected by gut microbes, including obesity, diabetes, neurodegenerative disease and perhaps even cancer," the university wrote in a news release.

Although the cause and cure for IBD are unknown, the early-stage study shows that it may be possible to use phage therapy to relieve some painful symptoms of UC and CD.

"Our vision is to eventually develop personalized therapies for a variety of disorders, in which the disease-causing strains of gut bacteria will be identified in each patient, and a phage cocktail will be designed to kill only those strains," Dr Elinav said.

"​​These exciting prospects merit further studies," the researchers wrote.

Cell. 2022;185(16):2879-2898.[1]

Study Highlights

  • Across 4 geographically distinct IBD cohorts (n=537) in France, Israel, the United States, and Germany, researchers identified a clade of Kp strains with unique antibiotics resistance and mobilome signature that were strongly associated with IBD exacerbation and severity.
  • Transferring Kp strains that were clinically associated with IBD and isolated from stool samples into colitis-prone, germ-free, and colonized mice enhanced intestinal inflammation.
  • Through stepwise generation and testing of 41 phages infecting Kp, researchers developed a lytic 5-phage combination based on genetic profiles, structural features seen on microscopy, and extensive combinatorial screening for activity against various Kp strains, including antibiotic- resistant strains.
  • This phage cocktail targeted sensitive and resistant IBD-associated Kp clade members via distinct mechanisms.
  • Treating colitis-prone mice with this lytic 5-phage combination resulted in effective Kp suppression, leading to attenuated inflammation, tissue damage, and disease severity.
  • Proof-of-concept assessment of Kp-targeting phages showed that they were stable in an artificial human gut.
  • In a first-in-human phase I clinical trial of 18 healthy volunteers, the orally administered combination phage therapy was well-tolerated, with phage multiplication and accumulation in the lower gut, no off-target changes, and gastric acid-dependent phage resilience, safety, and viability.
  • The investigators concluded that their orally administered combination phage therapy was feasible to avoid resistance, while effectively inhibiting bacterial pathogens contributing to noncommunicable disease such as IBD.
  • They described their orally administered combination phage therapy as the first "silver bullet" approach offering precise suppression of disease-causing gut microbes without harming the surrounding microbiome.
  • The study suggests that IBD could be managed with treatment other than antibiotics, which are less specific, may have adverse effects, and promote emergence of antibiotic resistance and MDR organisms.
  • The techniques used in this study may facilitate identification of specific clades of disease-contributing bacteria and strains ("driver" strains) while differentiating them from many other strains present at altered levels secondary to disease-related processes ("passenger" strains).
  • This could help target treatment toward pathogenic strains in given clinical contexts.
  • As lytic phages self-replicate in the host, phages would self-maintain as long as target pathogen levels exceed a threshold, but then decline once bacterial target suppression is achieved.
  • Given the resistance-avoiding qualities of phages given orally, the investigators are hopeful that phage therapy will 1 day be used with induction therapy in IBD to help quench acute disease exacerbation, or as maintenance therapy, in which chronic bacterial phage suppression may delay or prevent disease flare-ups.
  • As phage-resistant bacteria often have enhanced susceptibility to antibiotics, phage therapy combined with antibiotics may generate synergistic activity even when pathogens have shown antibiotic resistance.
  • If the phage cocktail is found to be safe and effective in larger clinical trials, it could potentially lead to the development of treatments for IBD and other conditions affected by gastrointestinal bacteria, including obesity, diabetes, neurodegenerative disease, and perhaps even cancer.
  • Although the cause and cure for IBD are unknown, improvement of inflammation and tissue damage induced by the phage cocktail suggests that phage therapy may ultimately relieve some painful symptoms of UC and CD.
  • Although further research is needed, personalized therapies might ultimately be developed for a variety of disorders, in which the disease-causing strains of gut bacteria would be identified in each patient and a phage cocktail could be designed to target only those strains.
  • The effect of diet, age, and oral versus colonoscopy administration methods and transit time on the gut microbiome and effectiveness of phage treatment should be studied further.
  • Combined oral and systemic phage administration might optimize therapy, especially against invasive pathogens, but further studies are needed.

Clinical Implications

  • Orally administered combination phage therapy was feasible to avoid development of antibiotic resistance while effectively inhibiting bacterial pathogens contributing to IBD and potentially to other noncommunicable disease.
  • The investigators described their orally administered combination phage therapy as the first "silver bullet" approach offering precise suppression of disease-causing gut microbes without harming the surrounding microbiome.
  • Implications for the Health Care Team: The study suggests that IBD could be managed with treatment other than antibiotics, which are less specific, may have adverse effects, and promote emergence of antibiotic resistance and MDR organisms. Members of the healthcare team should provide education to patients on appropriate scenarios antibiotic use and continue to practice good antibiotic stewardship.

 

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