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5. Alanyl-glutamine Supplementation for Clostridioides difficile Infection Treatment (ACT): A double-blind randomized controlled trial

Author

Warren, Cirle A., Shin, Jae Hyun, Bansal, Ekta N., Costa, Deiziane V. D. S., Wang, Xin Qun, Wu, Martin, Swann, Jonathan R., Behm, Brian W., Targonski, Paul V., Archbald-Pannone, Laurie, Warren, Cirle A., Shin, Jae Hyun, Bansal, Ekta N., Costa, Deiziane V. D. S., Wang, Xin Qun, Wu, Martin, Swann, Jonathan R., Behm, Brian W., Targonski, Paul V., and Archbald-Pannone, Laurie

Abstract

Introduction: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. Methods and analysis: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. Ethics and dissemination: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. Trial registration number NCT04305769.

Published
2023

27. Polypharmacy is a risk factor for disease flare in adult patients with ulcerative colitis: a retrospective cohort study.

Author

Jingzhou Wang, Nakamura, Takahiro I., Tuskey, Anne G., and Behm, Brian W.

Subjects
POLYPHARMACY, ULCERATIVE colitis
Abstract

Polypharmacy is a common clinical problem with chronic diseases that can be associated with adverse patient outcomes. The present study aimed to determine the prevalence and patient-specific characteristics associated with polypharmacy in an ulcerative colitis (UC) population and to assess the impact of polypharmacy on disease outcomes. Methods: A retrospective chart review of patients with UC who visited a tertiary medical center outpatient clinic between 2006 and 2011 was performed. Polypharmacy was defined as major (= 5 non-UC medications) or minor (2-4 non-UC medications). UC medications were excluded in the polypharmacy grouping to minimize the confounding between disease severity and polypharmacy. Outcomes of interest include disease flare, therapy escalation, UC-related hospitalization, and surgery within 5 years of the initial visit. Results: A total of 457 patients with UC were eligible for baseline analysis. Major polypharmacy was identified in 29.8% of patients, and minor polypharmacy was identified in 40.9% of the population. Polypharmacy at baseline was associated with advanced age (P< 0.001), female sex (P= 0.019), functional gastrointestinal (GI) disorders (P< 0.001), and psychiatric disease (P< 0.001). Over 5 years of follow-up, 265 patients remained eligible for analysis. After adjusting for age, sex, functional GI disorders, and psychiatric disease, major polypharmacy was found to be significantly associated with an increased risk of disease flare (odds ratio, 4.00; 95% confidence interval, 1.66-9.62). However, major polypharmacy was not associated with the risk of therapy escalation, hospitalization, or surgery. Conclusions: Polypharmacy from non-inflammatory bowel disease medications was present in a substantial proportion of adult patients with UC and was associated with an increased risk of disease flare. [ABSTRACT FROM AUTHOR]

Published
2019
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29. Zinc Deficiency and the Recurrence of Clostridium difficile Infection after Fecal Microbiota Transplant: A Retrospective Cohort Study.

Author

Niccum, Blake A., Stein, Daniel J., Behm, Brian W., and Hays, R. Ann

Abstract

Background. Fecal microbiota transplant (FMT) is an effective therapy for recurrent Clostridium difficile infection (CDI). However, in 12% of patients treated with FMT, CDI recurs within one month. Zinc deficiency predicts increased diarrheal frequency in malnourished children, but little is known about its association with FMT outcome. We hypothesized that zinc levels were an independent predictor of CDI recurrence after FMT. Methods. We performed a retrospective cohort study of 80 patients (mean age, 66; 59 women) receiving FMT for CDI from 9/2013–9/2016 at a tertiary care center. Zinc levels were measured within 90 days before FMT. The primary outcome was CDI recurrence within 90 days after FMT. We controlled for risk factors for FMT failure using Cox regression. We also analyzed the effect of zinc supplementation in individuals with deficiency. Results. Forty-nine subjects had a normal zinc level, and 31 had a low level (<0.66 µg/mL). CDI recurred in 3/49 (6%) patients with normal zinc and 5/31 (16%) patients with low zinc (HR = 11.327, 95% CI = 2.162–59.336, p=0.004). Among low zinc subjects, 2 of 25 (8%) that received zinc supplements and 3 of 6 (50%) that did not receive zinc supplements had recurrence of CDI (HR = 0.102, 95% CI = 0.015–0.704, p=0.021). Conclusion. Zinc deficiency was associated with increased CDI recurrence after FMT. Among zinc-deficient patients, supplementation was associated with reduced recurrence. Further study is needed to determine whether zinc deficiency represents a pathophysiologic mechanism and target for therapy. [ABSTRACT FROM AUTHOR]

Published
2018
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33. Profile of ustekinumab and its potential in patients with moderate-to-severe Crohn's disease

Author

Tuskey,Anne, Behm,Brian W, Tuskey,Anne, and Behm,Brian W

Abstract

Anne Tuskey, Brian W Behm Division of Gastroenterology and Hepatology, University of Virginia School of Medicine, Charlottesville, VA, USA Abstract: The advent of anti-tumor necrosis factor (TNF)-α therapy has been a major advance in the medical management of Crohn's disease (CD). However, a significant proportion of patients with CD do not respond adequately to treatment with these agents. Primary and secondary nonresponse to anti-TNFα therapy represents a common clinical challenge, and highlights the need for the development of additional medication options for CD. The proinflammatory cytokines interleukin (IL)-12 and IL-23 are thought to play a key role in the pathogenesis of CD, and serve as a potential target for additional biologic therapies. Monoclonal antibodies targeting IL-12/23 have shown efficacy in animal models of colitis, and are currently being studied in Phase III clinical trials of CD. This review focuses on ustekinumab, a fully human immunoglobulin G1 monoclonal antibody, which blocks activity of IL-12 and IL-23 through binding the p40 subunit, and describes the current efficacy and safety data for ustekinumab in patients with CD. Keywords: Crohn's disease, ustekinumab, clinical trials, inflammatory bowel disease

Published
2014

45. Response

Author

Wang, Andrew Y., primary, Sauer, Bryan G., additional, Behm, Brian W., additional, Ramanath, Madhuri, additional, Cox, Dawn G., additional, Ellen, Kristi L., additional, Shami, Vanessa M., additional, and Kahaleh, Michel, additional

Published
2011
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