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      Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial

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          Abstract

          Background

          Recurrence of Clostridioides difficile infection (rCDI) is common, prolonging disease morbidity and leading to poor quality of life. We evaluated disease-specific health-related quality of life (HRQL) in patients with rCDI treated with fecal microbiota, live-jslm (REBYOTA [RBL]; Rebiotix) versus placebo.

          Methods

          This was a secondary analysis of a randomized, double-blind, placebo-controlled phase 3 study (PUNCH CD3). The disease-specific Clostridioides difficile Quality of Life Survey (Cdiff32) was administered at baseline and at weeks 1, 4, and 8. Changes in Cdiff32 total and domain (physical, mental, social) scores from baseline to week 8 were compared between RBL and placebo and for responders and nonresponders.

          Results

          Findings were analyzed in a total of 185 patients (RBL, n = 128 [69.2%]; placebo, n = 57 [30.8%]) with available Cdiff32 data. Patients from both arms showed significant improvements in Cdiff32 scores relative to baseline across all outcomes and at all time points (all P < .001); RBL-treated patients showed significantly greater improvements in mental domain than those receiving placebo. In adjusted analyses, RBL-treated patients showed greater improvements than placebo in total score and physical and mental domains (all P < .05). Similar improvement in mental domain was observed among responders, while nonresponders showed numerical improvements with RBL but not placebo.

          Conclusions

          In a phase 3 double-blinded clinical trial, RBL-treated patients reported more substantial and sustained disease-specific HRQL improvements than placebo-treated patients.

          Clinical Trials Registration

          ClinicalTrials.gov NCT03244644 ( https://clinicaltrials.gov/ct2/show/NCT03244644).

          Abstract

          We found significantly greater improvements in mental, physical, and overall health-related quality of life in patients with recurrent Clostridioides difficile infection treated with fecal microbiota, live-jslm (REBYOTA [RBL]) than in placebo-treated patients in a randomized, placebo-controlled trial (PUNCH CD3).

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          Most cited references33

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          Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve.

          J A Bravo, P Forsythe, M. V. Chew … (2011)
          There is increasing, but largely indirect, evidence pointing to an effect of commensal gut microbiota on the central nervous system (CNS). However, it is unknown whether lactic acid bacteria such as Lactobacillus rhamnosus could have a direct effect on neurotransmitter receptors in the CNS in normal, healthy animals. GABA is the main CNS inhibitory neurotransmitter and is significantly involved in regulating many physiological and psychological processes. Alterations in central GABA receptor expression are implicated in the pathogenesis of anxiety and depression, which are highly comorbid with functional bowel disorders. In this work, we show that chronic treatment with L. rhamnosus (JB-1) induced region-dependent alterations in GABA(B1b) mRNA in the brain with increases in cortical regions (cingulate and prelimbic) and concomitant reductions in expression in the hippocampus, amygdala, and locus coeruleus, in comparison with control-fed mice. In addition, L. rhamnosus (JB-1) reduced GABA(Aα2) mRNA expression in the prefrontal cortex and amygdala, but increased GABA(Aα2) in the hippocampus. Importantly, L. rhamnosus (JB-1) reduced stress-induced corticosterone and anxiety- and depression-related behavior. Moreover, the neurochemical and behavioral effects were not found in vagotomized mice, identifying the vagus as a major modulatory constitutive communication pathway between the bacteria exposed to the gut and the brain. Together, these findings highlight the important role of bacteria in the bidirectional communication of the gut-brain axis and suggest that certain organisms may prove to be useful therapeutic adjuncts in stress-related disorders such as anxiety and depression.
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            Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA)

            L McDonald, Dale Gerding, Stuart Johnson … (2018)
            A panel of experts was convened by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) to update the 2010 clinical practice guideline on Clostridium difficile infection (CDI) in adults. The update, which has incorporated recommendations for children (following the adult recommendations for epidemiology, diagnosis, and treatment), includes significant changes in the management of this infection and reflects the evolving controversy over best methods for diagnosis. Clostridium difficile remains the most important cause of healthcare-associated diarrhea and has become the most commonly identified cause of healthcare-associated infection in adults in the United States. Moreover, C. difficile has established itself as an important community pathogen. Although the prevalence of the epidemic and virulent ribotype 027 strain has declined markedly along with overall CDI rates in parts of Europe, it remains one of the most commonly identified strains in the United States where it causes a sizable minority of CDIs, especially healthcare-associated CDIs. This guideline updates recommendations regarding epidemiology, diagnosis, treatment, infection prevention, and environmental management.
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              Burden ofClostridium difficileInfection in the United States

              Fernanda Lessa, Yi Mu, Wendy Bamberg … (2015)
              The magnitude and scope of Clostridium difficile infection in the United States continue to evolve.
              Article 0 comments Cited 391 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Kevin W Garey:
                ORCID: https://orcid.org/0000-0003-2063-7503
                Erik R Dubberke
                Amy Guo
                Adam Harvey
                Min Yang
                Viviana García-Horton
                Mirko Fillbrunn
                Hongjue Wang
                Glenn S Tillotson
                Lindy L Bancke
                Paul Feuerstadt
                Journal
                Journal ID (nlm-ta): Open Forum Infect Dis
                Journal ID (iso-abbrev): Open Forum Infect Dis
                Journal ID (publisher-id): ofid
                Title: Open Forum Infectious Diseases
                Publisher: Oxford University Press (US )
                ISSN (Electronic): 2328-8957
                Publication date Collection: August 2023
                Publication date (Electronic): 20 July 2023
                Publication date PMC-release: 20 July 2023
                Volume: 10
                Issue: 8
                Electronic Location Identifier: ofad383
                Affiliations
                University of Houston , Houston, Texas, USA
                Washington University , St Louis, Missouri, USA
                Ferring Pharmaceuticals , Parsippany, New Jersey, USA
                Rebiotix, a Ferring Company , Roseville, Minnesota, USA
                Analysis Group Inc., Boston, Massachusetts, USA
                Analysis Group, Inc., New York, New York, USA
                Analysis Group Inc., Boston, Massachusetts, USA
                Analysis Group Inc., Boston, Massachusetts, USA
                GST Micro, North, Virginia, USA
                Rebiotix, a Ferring Company , Roseville, Minnesota, USA
                Yale University School of Medicine , New Haven, Connecticut, USA
                PACT-Gastroenterology Center , New Haven, Connecticut, USA
                Author notes
                Correspondence: Kevin W. Garey, PharmD, MS, 4349 Martin Luther King Blvd, HBS2 Bldg, Room 4039, Houston, TX 77204-5000 ( kgarey@ 123456uh.edu ); Min Yang, MD, PhD, 111 Huntington Ave, 14th Floor, Boston MA 02199 ( min.yang@ 123456analysisgroup.com ).

                Potential conflict of interest. A. G. is an employee of Ferring Pharmaceuticals. A. H. and L. L. B. are employees of Rebiotix, a Ferring Company. M. Y., V. G. H., M. F., and H. W. are employees of Analysis Group, which received payment from Ferring Pharmaceuticals for participation in this research. G. S. T. is an employee of GST Micro and a consultant for Ferring Pharmaceuticals, Spero, and Taro Pharmaceuticals. K. W. G. is an employee of the University of Houston College of Pharmacy and a consultant for Ferring Pharmaceuticals and has received research grants from Acurx, Summit, Paratek Pharmaceuticals, and Seres Health. E. R. D. is an employee of Washington University School of Medicine; is a consultant for and Ferring, Pfizer, Abbott, Merck, Seres, and Summit; has received research grants from Ferring, Pfizer, and Synthetic Biologics; and is a member of the advisory board for Rebiotix. P. F. is an employee of Yale University School of Medicine; a consultant for Ferring Pharmaceuticals/Rebiotix, Seres Therapeutics, and Merck and Co; a member of the speakers’ bureau for Ferring Pharmaceuticals/Rebiotix; and an advisory board member for Ferring Pharmaceuticals/Rebiotix, Seres Therapeutics, and Takeda Pharmaceuticals.

                Author information
                https://orcid.org/0000-0003-2063-7503
                Article
                Publisher ID: ofad383
                DOI: 10.1093/ofid/ofad383
                PMC ID: 10411038
                SO-VID: fca34239-af86-4bbf-9abd-fd73258a41a5
                Copyright © © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 12 April 2023
                Date: 19 June 2023
                Date accepted : 18 July 2023
                Date: 09 August 2023
                Page count
                Pages: 7
                Funding
                Funded by: Ferring Pharmaceuticals, DOI 10.13039/501100003122;
                Categories
                Subject: Major Article
                Subject: Transfer from CID
                Subject: AcademicSubjects/MED00290

                Keywords: fecal microbiota,health-related quality of life,live-jslm,randomized clinical trial, clostridioides difficile infection
                Data availability:
                Keywords: fecal microbiota, health-related quality of life, live-jslm, randomized clinical trial, clostridioides difficile infection

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