Management of Severe and Severe/Complicated Clostridoides difficile Infection using Sequential Fecal Microbiota Transplant by Retention Enema

2021 ◽  
Author(s):  
Abbas Hatim Rupawala ◽  
Darrel Gachette ◽  
Mena Bakhit ◽  
Lanre Jimoh ◽  
Colleen R Kelly
Keyword(s):  
Adverse Events ◽  
Antibiotic Therapy ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Fecal Microbiota Transplant ◽  
Retention Enema ◽  
Initial Improvement

Abstract We evaluated serial FMT by retention enema in patients with severe or severe/complicated CDI unresponsive to at least 48 hours of standard antibiotic therapy. Of the 15 patients included, despite initial improvement in most patients, only 5 patients sustained cure at 30 days and serious adverse events occurred in 4 patients.

scholarly journals 1122. Evaluation of Fecal Microbiota Transplant (FMT) in Elderly Patients With recurrent Clostridium difficile Infection (CDI)

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S336-S336 ◽  
Author(s):  
Ali Hassoun ◽  
Jonathan Edwards
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Success Rate ◽  
Fecal Microbiota ◽  
Age Group ◽  
Serious Adverse Events ◽  
Fecal Microbiota Transplant ◽  
Treatment Regimens ◽  
Recurrent Clostridium Difficile Infection ◽  
Deadly Disease

Abstract Background CDI is a bacterial infection that typically occurs after the use of broad-spectrum antibiotics. Older adults are particularly susceptible to this potentially deadly disease and at higher risk of recurrence. Methods The study was approved by the hospital’s IRB. Patients 65 years of age and older with refractory or recurrent CDI who received FMT administered via colonoscopy or oral capsules were included. Patients with severe-complicated infection were excluded and ineligible to receive FMT. Each patient was evaluated 8 weeks post-transplant to assess for sustained clinical response and adverse events. Data collection included patient demographics, number of recurrent CDI episodes, CDI severity, previous antibiotic treatment regimens, clinical cure, adverse events, and donor information. Results Thirty-five patients were enrolled (23 colonoscopy FMT vs. 13 oral capsule FMT). One patient received FMT via colonoscopy twice. Mean age was 77 years [65–93], female 60%, median recurrent episode was 3, and median CDI severity score was 2. Total success rate was 69.4% (25/36), 60.9% (14/23) via colonoscopy vs. 84.6% (11/13) via capsule. Total success rate for female 67% vs. 73% male and age group of 65–75 was 60% vs. 76% in age group 75+. For capsules only, cure rate was 80% in female vs. 100% in male and 75% in 65–75 age group vs. 89% in patients older than 75 while in colonoscopy only group, success rate was 55% in female vs. 67% in males and 46% in 65–75 age group vs. 67% in age group 75+. There did not seem to be a correlation between FMT donor and success rate. No serious adverse events were reported in the study population. Conclusion FMT may be considered a potentially useful therapy for the treatment of refractory or recurrent CDI cases in patients 65 years of age and older. Further studies are needed to confirm the above findings. Older adults are particularly susceptible to this potentially deadly disease Disclosures All authors: No reported disclosures.

scholarly journals A Systematic Review of the Efficacy and Safety of Fecal Microbiota Transplant for Clostridium difficile Infection in Immunocompromised Patients

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Oluwaseun Shogbesan ◽  
Dilli Ram Poudel ◽  
Samjeris Victor ◽  
Asad Jehangir ◽  
Opeyemi Fadahunsi ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
English Language ◽  
Fecal Microbiota Transplantation ◽  
Secondary Infection ◽  
Organ Transplant ◽  
Fecal Microbiota ◽  
Immunocompromised Patients ◽  
Serious Adverse Events ◽  
Fecal Microbiota Transplant ◽  
Immunosuppressant Medications

Background. Fecal microbiota transplantation (FMT) has been shown to be effective in recurrent Clostridium difficile (CD) infection, with resolution in 80% to 90% of patients. However, immunosuppressed patients were often excluded from FMT trials, so safety and efficacy in this population are unknown. Methods. We searched MEDLINE and EMBASE for English language articles published on FMT for treatment of CD infection in immunocompromised patients (including patients on immunosuppressant medications, patients with human immunodeficiency virus (HIV), inherited or primary immunodeficiency syndromes, cancer undergoing chemotherapy, or organ transplant, including-bone marrow transplant) of all ages. We excluded inflammatory bowel disease patients that were not on immunosuppressant medications. Resolution and adverse event rates (including secondary infection, rehospitalization, and death) were calculated. Results. Forty-four studies were included, none of which were randomized designs. A total of 303 immunocompromised patients were studied. Mean patient age was 57.3 years. Immunosuppressant medication use was the reason for the immunocompromised state in the majority (77.2%), and 19.2% had greater than one immunocompromising condition. Seventy-six percent were given FMT via colonoscopy. Of the 234 patients with reported follow-up outcomes, 207/234 (87%) reported resolution after first treatment, with 93% noting success after multiple treatments. There were 2 reported deaths, 2 colectomies, 5 treatment-related infections, and 10 subsequent hospitalizations. Conclusion. We found evidence that supports the use of FMT for treatment of CD infection in immunocompromised patients, with similar rates of serious adverse events to immunocompetent patients.

scholarly journals The Clinical and Steroid-Free Remission of Fecal Microbiota Transplantation to Patients with Ulcerative Colitis: A Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Wai Ching Lam ◽  
Chen Zhao ◽  
Wen Juan Ma ◽  
Liang Yao
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Cohort Studies ◽  
Clinical Response ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomized Controlled

Background and Purpose. Since the first case of fecal microbiota transplantation for the treatment of ulcerative colitis was described in the year 1989, there have been an increment of case reports, case series, cohort studies, and randomized controlled trials (RCTs). In this study, we were going to investigate general clinical remission, clinical response, and steroid-free remission of fecal microbiota transplantation. Methods. We searched Ovid Medline, Ovid EMBASE, and Cochrane Library, focusing prospective studies including randomized controlled trials and cohort studies. The outcomes were clinical remission, clinical response, steroid-free remission, and serious adverse events. We used RevMan 5.3 software for meta-analyses. Key Results. A total of 4 RCTs and 2 cohort studies (340 cases from 5 countries) were included. We found that FMT might be more effective than placebo on clinical remission (OR, 3.85 [2.21, 6.7]; P<0.001; I2=0%) and clinical response (OR, 2.75 [1.33, 5.67]; P=0.006; I2=49%), but no statistical difference on steroid-free remission (OR, 2.08 [0.41, 10.5]; P=0.37; I2=69%) and serious adverse events (OR, 2.0 [0.17, 22.97]; P=0.44; I2=0%). Conclusions and Inferences. Fecal microbiota transplantations were associated with significant clinical remission and response in ulcerative colitis patients while there was no significant difference found between FMT and placebo in steroid-free remission. Moreover, a common consensus on the route, volume, timing, preferred donor characteristics, and frequency of fecal administration is necessary to achieve remission.

scholarly journals Clinical and Economic Evaluation of commercialized Fecal Microbiota Transplant (cFMT) for Patients with Recurrent Clostridium difficile Infection (CDI) in a Large Community Hospital

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S385-S385
Author(s):  
Ali Hassoun ◽  
Jonathan Edwards ◽  
Brian Boyett
Keyword(s):  
Antibiotic Therapy ◽  
Clinical Cure ◽  
Community Hospital ◽  
Severe Infection ◽  
Fecal Microbiota ◽  
Fecal Microbiota Transplant ◽  
Recurrent Clostridium Difficile Infection ◽  
Outpatient Center ◽  
The Cost ◽  
Antimicrobial Regimen

Abstract Background Recurrent CDI is common despite antibiotic therapy. FMT is effective to reduce recurrent infections. We report our experience with Commercialized FMT (cFMT) products by providing ready-to-use capsules, for oral administration, or solution, for administration via colonoscopy. Methods The study was approved by IRB for adult patients with at least 3 episode of recurrent CDI despite antibiotic therapy, patients with severe infection were excluded. cFMT was administered in the hospital or at outpatient center. Each patient was evaluated 8 weeks post-transplant to assess for sustained clinical cure and side effects. The economic impact of cFMT was evaluated using historical data from EHR including: CDI rate, CDI readmission rate, rate of CDI-associated death, cost of CDI admissions, and rate of use of each antimicrobial regimen Results 33 patients enrolled (solution/colonoscopy 20 and capsule 13). Mean age was 74 vs. 67 y, female 56% vs. 64%, recurrent episode 4 vs. 3.1, CDI severity score 1.4 vs. 1.2. 95% (19/20) of patients who received cFMT via colonoscopy experienced sustained clinical cure vs. 85% (11/13) of patients who received capsule. One patient experienced an adverse event from capsule with nausea and vomiting, which resolved without sequelae. 2 of the 3 patients that experienced treatment failure received cFMT from the same donor Due to recurrent episodes. The cost of cFMT was $635 for capsules and $485 for solution which was far less than recurrent CDI associated cost. Conclusion cFMT is a viable alternative to traditional FMT and was both clinically and economically beneficial in patients with recurrent CDI in a community hospital. Further studies needed to confirm above findings. Disclosures All authors: No reported disclosures.

scholarly journals Mo1961 – Inpatient Management of Severe Clostridium Infection Using Fecal Microbiota Transplant Via Retention Enema

2019 ◽  
Vol 156 (6) ◽  
pp. S-902
Author(s):  
Darrel Gachette ◽  
Mena Bakhit ◽  
Abbas H. Rupawala ◽  
Lanre Jimoh ◽  
Colleen R. Kelly
Keyword(s):  
Fecal Microbiota ◽  
Fecal Microbiota Transplant ◽  
Retention Enema ◽  
Inpatient Management

Shiga Toxin–Producing Escherichia coli Transmission via Fecal Microbiota Transplant

2020 ◽  
Author(s):  
Caroline Zellmer ◽  
Mohamad R A Sater ◽  
Miriam H Huntley ◽  
Majdi Osman ◽  
Scott W Olesen ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Adverse Events ◽  
Shiga Toxin ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Fecal Microbiota Transplant ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Recommended Therapy

Abstract Fecal microbiota transplantation (FMT) is recommended therapy for multiply recurrent Clostridioides difficile infection. We report adverse events in 7 patients who received FMT from a stool donor who was colonized with Shiga toxin–producing Escherichia coli (STEC). No patients died of FMT-transmitted STEC. Improved screening can likely avoid future transmission.

scholarly journals Fecal Microbiota Transplantation as Therapy for Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolei Liu ◽  
Yan Li ◽  
Kaichun Wu ◽  
Yongquan Shi ◽  
Min Chen
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Meta Analysis ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Endoscopic Remission

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.

scholarly journals Safety and Potential Risks with Fecal Microbiota Transplantation

2021 ◽  
Author(s):  
Pratyusha Gaonkar
Keyword(s):  
Adverse Events ◽  
Therapeutic Potential ◽  
Fecal Microbiota Transplantation ◽  
Standard Of Care ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Recurrent Clostridium Difficile Infection ◽  
Long Term Follow Up

The therapeutic potential of Fecal Microbiota Transplantation (FMT) is greatly proved worldwide in the recent years. The use of FMT is now an accepted treatment modality and effective standard of care for some patients owing to its success in treating recurrent Clostridium Difficile Infection (rCDI). However, it is still evolving and longer term follow-up data regarding safety are required. Post-FMT serious adverse events (SAEs) have been varied between studies, however have included significant morbidity necessitating hospital admission and mortality in the follow-up period. The follow-up of FMT recipients should be long enough to completely establish efficacy/adverse events. Furthermore, it is recommended that FMT should be offered with caution to immunosuppressed patients, in whom FMT appears efficacious without significant additional adverse effects. In the wake of COVID-19 situation, stringent policies in screening the FMT donors have to be put forth to ensure patient safety. There is a need for high-quality, large, prospective, randomized controlled trials and long-term follow-up investigating screened donors and recipients to evaluate the long term safety and the risk–benefit profile of this promising therapy.

scholarly journals Efficacy and Safety of Fecal Microbiota Transplantation for the treatment of Clostridium difficile Infection in Patients with Liver Cirrhosis: a single center experience

2018 ◽  
Vol 1 (1) ◽  
Author(s):  
Dana Alhaffar, BS ◽  
Emmalee Phelps, BS ◽  
Monika Fischer, MD
Keyword(s):  
Liver Cirrhosis ◽  
Adverse Events ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Infectious Complications ◽  
Decompensated Cirrhosis ◽  
Efficacy And Safety ◽  
Multicenter Studies ◽  
Fecal Microbiota Transplant ◽  
Single Center Experience

Background and Hypothesis: Fecal microbiota transplant (FMT) is an effective therapy approaching a 90% success rate for recurrent and severe CDI. However, patients with liver cirrhosis are generally excluded from FMT trials due to concerns of infectious complications. We aimed to investigate the efficacy and safety of FMT in these patients.  Project Methods: Electronic medical records (Cerner) and an institutional FMT database (REDCap) were utilized to gather data on patient demographics, medical history, and follow-up. Inclusion criteria were the diagnosis of liver cirrhosis and FMT to treat CDI. The primary outcomes were FMT success at 8 weeks and adverse events within 12 weeks post-FMT.   Results: Among the 267 patients in the database, 15 had liver cirrhosis. Among these, 47% (N=7) were female. The average age was 61 years (range 28-83) and they received FMT between 2014 and 2017. There were 12 (80%) patients with recurrent CDI and 3 (20%) with severe CDI. Eleven patients had decompensated cirrhosis; Child-Pough scores were A: N=4, B: N=8, and C: N=3. Five (33%) failed before 8 weeks and needed 1-3 additional FMTs for cure. Fourteen (93.3%) patients experienced adverse events. Five patients experienced unrelated SAEs (Table).   Conclusion: Patients with liver cirrhosis failed FMT more often than non-cirrhotic historical controls. While numerous AEs and SAEs were reported, few of the AEs were possibly related to the FMT and none of the SAEs were FMT-related. Importantly, no infectious complications were observed. Larger, multicenter studies are needed to establish efficacy and safety of FMT in cirrhotics before it can be recommended for widespread use.

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