Browsing by Author "Allegretti, Jessica R."

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    The 5D Framework: A Clinical Primer for Fecal Microbiota Transplantation to Treat Clostridium difficile infection
    (Elsevier, 2017) Allegretti, Jessica R.; Kassam, Zain; Osman, Majdi; Budree, Shrish; Fischer, Monika; Kelly, Colleen R.; Department of Medicine, IU School of Medicine
    Clostridium difficile infection is the most common health care–associated infection in the United States. Recently, fecal microbiota transplantation (FMT) has emerged as an effective and safe therapy for recurrent C difficile infection; however, despite rapid adoption there is no standardized clinical approach. Given the rapid adoption of FMT, in part because of stool banks, there is a need for a practical primer for clinicians to safely perform FMT. Accordingly, we aim to provide a simple approach entitled the 5D FMT framework to guide physicians. The 5D FMT framework includes: decision (selecting appropriate patient for FMT), donor (selection and screening), discussion (risk, benefits, alternatives), delivery (selecting appropriate modality for FMT administration), and discharge (counseling at discharge and follow-up). We aim to help clinicians take a simple but evidence-based approach to FMT to optimize efficacy and safety. This primer navigates how to decide whether a patient with C difficile infection is appropriate for FMT and how to select and screen stool donors, identify the ideal delivery modality, and provide follow-up care after FMT.
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    Fecal Microbiota Transplant Decreases Mortality in Patients with Refractory Severe or Fulminant Clostridioides difficile Infection
    (Elsevier, 2020) Cheng, Yao-Wen; Phelps, Emmalee; Nemes, Sara; Rogers, Nicholas; Sagi, Sashidhar; Bohm, Matthew; El-Halabi, Mustapha; Allegretti, Jessica R.; Kassam, Zain; Xu, Huiping; Fischer, Monika; Medicine, School of Medicine
    Background & Aims Fecal microbiota transplantation (FMT) is recommended for recurrent Clostridioides difficile infection (CDI). FMT cures nearly 80% of patients with severe or fulminant CDI (SFCDI) when utilized in a sequential manner. We compared outcomes of hospitalized patients before and after implementation of an FMT program for SFCDI and investigated whether the changes could be directly attributed to the FMT program. Methods We performed a retrospective analysis of characteristics and outcomes of patients hospitalized for SFCDI (430 hospitalizations) at a single center, from January 2009 through December 2016. We performed subgroup analyses of 199 patients with fulminant CDI and 110 patients with refractory SFCDI (no improvement after 5 or more days of maximal anti-CDI antibiotic therapy). We compared CDI-related mortality within 30 days of hospitalization, CDI-related colectomy, length of hospital stay, and readmission to the hospital within 30 days before (2009–2012) vs after (2013–2016) implementation of the inpatient FMT program. Results CDI-related mortality and colectomy were lower after implementation of the FMT program. Overall, CDI-related mortality was 10.2% before the FMT program was implemented vs 4.4% after (P = .02). For patients with fulminant CDI, CDI-related mortality was 21.3% before the FMT program was implemented vs 9.1% after (P = .015). For patients with refractory SFCDI, CDI-related mortality was 43.2% before the FMT program vs 12.1% after (P < .001). The FMT program significantly reduced CDI-related colectomy in patients with SFCDI (6.8% before vs 2.7% after; P = .041), in patients with fulminant CDI (15.7% before vs 5.5% after; P = .017), and patients with refractory SFCDI (31.8% vs 7.6%; P = .001). The effect of FMT program implementation on CDI-related mortality remained significant for patients with refractory SFCDI after we accounted for the underlying secular trend (odds ratio, 0.09 for level change; P = .023). Conclusions An FMT program significantly decreased CDI-related mortality among patients hospitalized with refractory SFCDI.
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    Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience
    (Wiley, 2018) Cheng, Yao-Wen; Phelps, Emmalee; Ganapini, Vincent; Khan, Noor; Ouyang, Fangqian; Xu, Huiping; Khanna, Sahil; Tariq, Raseen; Friedman-Moraco, Rachel J.; Woodworth, Michael H.; Dhere, Tanvi; Kraft, Colleen S.; Kao, Dina; Smith, Justin; Le, Lien; El-Nachef, Najwa; Kaur, Nirmal; Kowsika, Sree; Ehrlich, Adam; Smith, Michael; Safdar, Nasia; Misch, Elizabeth Ann; Allegretti, Jessica R.; Flynn, Ann; Kassam, Zain; Sharfuddin, Asif; Vuppalanchi, Raj; Fischer, Monika; Medicine, School of Medicine
    Fecal microbiota transplant (FMT) is recommended for Clostridium difficile infection (CDI) treatment; however, use in solid organ transplantation (SOT) patients has theoretical safety concerns. This multicenter, retrospective study evaluated FMT safety, effectiveness, and risk factors for failure in SOT patients. Primary cure and overall cure were defined as resolution of diarrhea or negative C difficile stool test after a single FMT or after subsequent FMT(s) ± anti‐CDI antibiotics, respectively. Ninety‐four SOT patients underwent FMT, 78% for recurrent CDI and 22% for severe or fulminant CDI. FMT‐related adverse events (AE) occurred in 22.3% of cases, mainly comprising self‐limiting conditions including nausea, abdominal pain, and FMT‐related diarrhea. Severe AEs occurred in 3.2% of cases, with no FMT‐related bacteremia. After FMT, 25% of patients with underlying inflammatory bowel disease had worsening disease activity, while 14% of cytomegalovirus‐seropositive patients had reactivation. At 3 months, primary cure was 58.7%, while overall cure was 91.3%. Predictors of failing a single FMT included inpatient status, severe and fulminant CDI, presence of pseudomembranous colitis, and use of non‐CDI antibiotics at the time of FMT. These data suggest FMT is safe in SOT patients. However, repeated FMT(s) or additional antibiotics may be needed to optimize rates of cure with FMT.
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    Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry
    (Elsevier, 2021-01) Kelly, Colleen R.; Yen, Eugene F.; Grinspan, Ari M.; Kahn, Stacy A.; Atreja, Ashish; Lewis, James D.; Moore, Thomas A.; Rubin, David T.; Kim, Alison M.; Serra, Sonya; Nersesova, Yanina; Fredell, Lydia; Hunsicker, Dea; McDonald, Daniel; Knight, Rob; Allegretti, Jessica R.; Pekow, Joel; Absah, Imad; Hsu, Ronald; Vincent, Jennifer; Khanna, Sahil; Tangen, Lyn; Crawford, Carl V.; Mattar, Mark C.; Chen, Lea Ann; Fischer, Monika; Arsenescu, Razvan I.; Feuerstadt, Paul; Goldstein, Jonathan; Kerman, David; Ehrlich, Adam C.; Wu, Gary D.; Laine, Loren; Medicine, School of Medicine
    Background & Aims Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. Methods Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. Results Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). Conclusions This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.
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    Fecal Microbiota Transplantation Is Safe and Effective in Patients With Clostridioides difficile Infection and Cirrhosis
    (Elsevier, 2020) Cheng, Yao-Wen; Alhaffar, Dana; Saha, Srishti; Khanna, Sahil; Bohm, Matthew; Phelps, Emmalee; Ghabril, Marwan; Orman, Eric; Sashidhar, Sagi; Rogers, Nicholas; Xu, Huiping; Khoruts, Alexander; Vaughn, Byron; Kao, Dina; Wong, Karen; Cammarota, Giovanni; Ianiro, Gianluca; Dhere, Tanvi; Kraft, Colleen S.; Mehta, Nirja; Woodworth, Michael H.; Allegretti, Jessica R.; Nativ, Lotem; Marcus, Jenna; El-Nachef, Najwa; Fischer, Monika; Medicine, School of Medicine
    Background & Aims Clostridioides difficile infection (CDI) harms a large proportion of patients with cirrhosis. Fecal microbiota transplantation (FMT) is recommended for recurrent CDI, but its effects in patients with cirrhosis have not been established. We performed a multicenter observational study to evaluate the efficacy and safety of FMT for CDI in patients with cirrhosis. Methods We performed a retrospective study of 63 adults with cirrhosis (median model for end-stage liver disease score, 14.5; 24 patients with decompensated cirrhosis) who underwent FMT for CDI from January 2012 through November 2018 at 8 academic centers in the United States, Canada, and Italy. We collected data on patient demographics and characteristics of cirrhosis, CDI, and FMT from medical records and compared differences among patients with different severities of cirrhosis, and FMT successes vs failures at the 8-week follow-up evaluation. We also obtained data on adverse events (AEs) and severe AEs within 12 weeks of FMT. Results Patients underwent FMT for recurrent CDI (55 of 63; 87.3%), severe CDI (6 of 63; 9.5%), or fulminant CDI (2 of 63; 3.2%) primarily via colonoscopy (59 of 63; 93.7%) as outpatients (47 of 63; 76.8%). FMT success was achieved for 54 patients (85.7%). Among FMT failures, a higher proportion used non-CDI antibiotics at the time of FMT (44.4% vs 5.6%; P < .001), had Child–Pugh scores of B or C (100% vs 37.7%; P < .001), used probiotics (77.8% vs 24.1%; P = .003), had pseudomembranes (22.2% vs 0; P = .018), and underwent FMT as inpatients (45.5% vs 19%; P = .039), compared with FMT successes. In multivariable analysis, use of non-CDI antibiotics at the time of FMT (odds ratio, 17.43; 95% CI, 2.00–152.03; P = .01) and use of probiotics (odds ratio, 11.9; 95% CI, 1.81–78.3; P = .01) were associated with a greater risk of FMT failure. FMT-related AEs occurred in 33.3% of patients (21 of 63)—most were self-limited abdominal cramps or diarrhea. There were only 5 severe AEs that possibly were related to FMT; none involved infection or death. Conclusions In a retrospective study, we found FMT to be safe and effective for the treatment of CDI in patients with cirrhosis.
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    Inflammatory Bowel Disease Outcomes Following Fecal Microbiota Transplantation for Recurrent C. difficile Infection
    (Oxford University Press, 2021-08-19) Allegretti, Jessica R.; Kelly, Colleen R.; Grinspan, Ari; Mullish, Benjamin H.; Hurtado, Jonathan; Carrellas, Madeline; Marcus, Jenna; Marchesi, Julian R.; McDonald, Julie A.K.; Gerardin, Ylaine; Silverstein, Michael; Pechlivanis, Alexandros; Barker, Grace F.; Blanco, Jesus Miguens; Alexander, James L.; Gallagher, Kate I.; Pettee, Will; Phelps, Emmalee; Nemes, Sara; Sagi, Sashidhar V.; Bohm, Matthew; Kassam, Zain; Fischer, Monika; Medicine, School of Medicine
    Background: Recurrent Clostridioides difficile infection (CDI) in patients with inflammatory bowel disease (IBD) is a clinical challenge. Fecal microbiota transplantation (FMT) has emerged as a recurrent CDI therapy. Anecdotal concerns exist regarding worsening of IBD activity; however, prospective data among IBD patients are limited. Methods: Secondary analysis from an open-label, prospective, multicenter cohort study among IBD patients with 2 or more CDI episodes was performed. Participants underwent a single FMT by colonoscopy (250 mL, healthy universal donor). Secondary IBD-related outcomes included rate of de novo IBD flares, worsening IBD, and IBD improvement-all based on Mayo or Harvey-Bradshaw index (HBI) scores. Stool samples were collected for microbiome and targeted metabolomic profiling. Results: Fifty patients enrolled in the study, among which 15 had Crohn's disease (mean HBI, 5.8 ± 3.4) and 35 had ulcerative colitis (mean partial Mayo score, 4.2 ± 2.1). Overall, 49 patients received treatment. Among the Crohn's disease cohort, 73.3% (11 of 15) had IBD improvement, and 4 (26.6%) had no disease activity change. Among the ulcerative colitis cohort, 62% (22 of 34) had IBD improvement, 29.4% (11 of 34) had no change, and 4% (1 of 34) experienced a de novo flare. Alpha diversity significantly increased post-FMT, and ulcerative colitis patients became more similar to the donor than Crohn's disease patients (P = 0.04). Conclusion: This prospective trial assessing FMT in IBD-CDI patients suggests IBD outcomes are better than reported in retrospective studies.
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    Outcomes of Fecal Microbiota Transplantation in Patients With Inflammatory Bowel Diseases and Recurrent Clostridioides difficile Infection
    (Elsevier, 2020) Allegretti, Jessica R.; Kelly, Colleen R.; Grinspan, Ari; Mullish, Benjamin H.; Kassam, Zain; Fischer, Monika; Medicine, School of Medicine
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    Reorganisation of faecal microbiota transplant services during the COVID-19 pandemic
    (BMJ Publishing Group, 2020-07-03) Ianiro, Gianluca; Mullish, Benjamin H.; Kelly, Colleen R.; Kassam, Zain; Kuijper, Ed J.; Ng, Siew C.; Iqbal, Tariq H.; Allegretti, Jessica R.; Bibbò, Stefano; Sokol, Harry; Zhang, Faming; Fischer, Monika; Costello, Samuel Paul; Keller, Josbert J.; Masucci, Luca; Prehn, Joffrey van; Quaranta, Gianluca; Quraishi, Mohammed Nabil; Segal, Jonathan; Kao, Dina; Satokari, Reetta; Sanguinetti, Maurizio; Tilg, Herbert; Gasbarrini, Antonio; Cammarota, Giovanni; Medicine, School of Medicine
    The COVID-19 pandemic has led to an exponential increase in SARS-CoV-2 infections and associated deaths, and represents a significant challenge to healthcare professionals and facilities. Individual countries have taken several prevention and containment actions to control the spread of infection, including measures to guarantee safety of both healthcare professionals and patients who are at increased risk of infection from COVID-19. Faecal microbiota transplantation (FMT) has a well-established role in the treatment of Clostridioides difficile infection. In the time of the pandemic, FMT centres and stool banks are required to adopt a workflow that continues to ensure reliable patient access to FMT while maintaining safety and quality of procedures. In this position paper, based on the best available evidence, worldwide FMT experts provide guidance on issues relating to the impact of COVID-19 on FMT, including patient selection, donor recruitment and selection, stool manufacturing, FMT procedures, patient follow-up and research activities.
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    The risk of inflammatory bowel disease flares after fecal microbiota transplantation: Systematic review and meta-analysis
    (Taylor & Francis, 2017-11-02) Qazi, Taha; Amaratunga, Thelina; Barnes, Edward L.; Fisher, Monika; Kassam, Zain; Allegretti, Jessica R.; Medicine, School of Medicine
    Several studies have suggested worsening in inflammatory bowel disease (IBD) activity following fecal microbiota transplantation (FMT). We aimed to assess the risk of worsening in IBD activity following FMT. An electronic search was conducted using MEDLINE (1946-June 2016), EMBASE (1954-June 2016) and Cochrane Central Register of Controlled Trials (2016). Studies in which FMT was provided to IBD patients for IBD management or (Clostridium difficile infection) CDI treatment were included. The primary outcome was the rate of worsening in IBD activity. Results: Twenty-nine studies with 514 FMT-treated IBD patients were included. Range of follow up was 4 weeks to 3 y. The pooled rate of IBD worsening was 14.9% (95% CI 10–21%). Heterogeneity was detected: I2 D 52.1%, Cochran Q test D 58.1, p D 0.01. A priori subgroup analyses were performed. Although not significant, the pooled rate of worsening in IBD activity following FMT for CDI (22.7% (95% CI: 13–36%)) was higher compared with FMT for IBD (11.1% (95% CI 7–17%)). Rates of worsening in IBD after lower GI FMT delivery revealed a higher rate of worsening in IBD activity (16.5% (95% CI: 11–24%)) compared with upper GI delivery (5.6% (95% CI: 2–16%)). Rates of worsening in high quality studies and randomized controls trials (RCTS) suggested a marginal risk of worsening in IBD activity (4.6%, (95% CI: 1.8–11%). Rates of IBD worsening are overall marginal across high quality RCTS. It is unknown if the FMT itself led to the worsening of IBD in this small fraction or if this represents alternative etiologies.
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    SARS-CoV-2 vaccines and donor recruitment for FMT
    (Elsevier, 2021) Ianiro, Gianluca; Mullish, Benjamin H.; Hvas, Christian Lodberg; Segal, Jonathan P.; Kuijper, Ed J.; Costello, Samuel P.; Kelly, Colleen R.; Allegretti, Jessica R.; Fischer, Monika; Iqbal, Tariq H.; Satokari, Reetta; Kao, Dina; van Prehn, Joffrey; Ng, Siew C.; Bibbò, Stefano; Dahl Baunwall, Simon Mark; Quraishi, Mohammed N.; Sokol, Harry; Zhang, Faming; Keller, Josbert; Masucci, Luca; Quaranta, Gianluca; Kassam, Zain; Sanguinetti, Maurizio; Tilg, Herbert; Gasbarrini, Antonio; Cammarota, Giovanni; Medicine, School of Medicine