scholarly journals The Efficacy and Safety of Fecal Microbiota Transplant for Recurrent Clostridiumdifficile Infection: Current Understanding and Gap Analysis

2020 ◽  
Vol 7 (5) ◽  
Author(s):  
Mark H Wilcox ◽  
Barbara H McGovern ◽  
Gail A Hecht
Keyword(s):  
Gap Analysis ◽  
Treatment Guidelines ◽  
Current Knowledge ◽  
Fecal Microbiota ◽  
Adverse Event Reporting ◽  
Efficacy And Safety ◽  
Fecal Microbiota Transplant ◽  
Symptomatic Disease ◽  
Wide Range ◽  
Suppressive Antibiotic Therapy

Abstract The leading risk factor for Clostridioides (Clostridium) difficile infection (CDI) is broad-spectrum antibiotics, which lead to low microbial diversity, or dysbiosis. Current therapeutic strategies for CDI are insufficient, as they do not address the key role of the microbiome in preventing C. difficile spore germination into toxin-producing vegetative bacteria, which leads to symptomatic disease. Fecal microbiota transplant (FMT) appears to reduce the risk of recurrent CDI through microbiome restoration. However, a wide range of efficacy rates have been reported, and few placebo-controlled trials have been conducted, limiting our understanding of FMT efficacy and safety. We discuss the current knowledge gaps driven by questions around the quality and consistency of clinical trial results, patient selection, diagnostic methodologies, use of suppressive antibiotic therapy, and methods for adverse event reporting. We provide specific recommendations for future trial designs of FMT to provide improved quality of the clinical evidence to better inform treatment guidelines.

scholarly journals Letrozole for Female Infertility

2021 ◽  
Vol 12 ◽  
Author(s):  
Ai-Min Yang ◽  
Na Cui ◽  
Yi-Fei Sun ◽  
Gui-Min Hao
Keyword(s):  
Clinical Trial ◽  
Aromatase Inhibitor ◽  
Ovulation Induction ◽  
Biosynthetic Pathway ◽  
Current Knowledge ◽  
Female Infertility ◽  
Efficacy And Safety ◽  
Estrogen Synthesis ◽  
Wide Range ◽  
Initial Clinical Trial

Letrozole, an aromatase inhibitor that blocks estrogen synthesis by inhibiting the final step of the estrogen biosynthetic pathway, has been used in the applications of a wide range of infertility settings. It has been more than 20 years since the initial clinical trial of letrozole for ovulation induction. In light of the accumulating clinical and basic evidence, the efficacy and safety of letrozole have been identified. This mini review focuses on our current knowledge of the applications and mechanisms of letrozole for female infertility and various questions are put forward about how letrozole could be more effectively used.

scholarly journals Effect of Fecal Microbiota Transplant on Symptoms of Psychiatric Disorders: A Systematic Review

2020 ◽  
Author(s):  
Arthi Chinna Meyyappan ◽  
Evan Forth ◽  
Caroline Wallace ◽  
Roumen Milev
Keyword(s):  
Fecal Microbiota ◽  
Efficacy And Safety ◽  
Gi Tract ◽  
Eligibility Criteria ◽  
Fecal Microbiota Transplant ◽  
Psychiatric Illnesses ◽  
Bidirectional Signaling ◽  
Key Terms ◽  
The Brain ◽  
Larger Sample

Abstract Background: The Gut-Brain-Axis is a bidirectional signaling pathway between the gastrointestinal (GI) tract and the brain. The hundreds of trillions of microorganisms populating the gastrointestinal tract are thought to modulate this connection, and have far reaching effects on the immune system, central and autonomic nervous systems, and GI functioning. These interactions have also been linked to various psychiatric illnesses such as depression, anxiety, substance abuse, and eating disorders. It is hypothesized that techniques aimed at strengthening and repopulating the gut microbiome, such as Fecal Microbiota Transplant (FMT), may be useful in the prevention and treatment of psychiatric illnesses. Methods: A systematic search of five databases was conducted using key terms related to FMT and psychiatric illnesses. All results were then evaluated based on specific eligibility criteria. Results: Twenty-one studies met the eligibility criteria and were analysed for reported changes in mood and behavioural measures indicative of psychiatric wellbeing. The studies included were either entirely clinical (n=7), preclinical with human donors (n=7), or entirely preclinical (n=7). All studies found a decrease in depressive and anxiety-like symptoms and behaviours resulting from the transplantation of healthy microbiota. The inverse was also found, with the transmission of depressive and anxiety-like symptoms and behaviours resulting from the transplantation of microbiota from psychiatrically ill donors to healthy recipients. Conclusion: There appears to be strong evidence for the treatment and transmission of psychiatric illnesses through FMT. Further research with larger sample sizes and stronger scientific design is warranted in order to fully determine the efficacy and safety of this potential treatment.

scholarly journals A265 SERIAL FECAL MICROBIOTA TRANSPLANT PLUS FIDAXOMICIN IN THE TREATMENT OF SEVERE OR FULMINANT CLOSTRIDIOIDES DIFFICILE INFECTION

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 142-143
Author(s):  
L Russell ◽  
B Roach ◽  
D Y Yang ◽  
C Wang ◽  
E Wine ◽  
...  
Keyword(s):  
Pilot Study ◽  
Medical Therapy ◽  
Fecal Microbiota ◽  
High Dose ◽  
Efficacy And Safety ◽  
Fecal Microbiota Transplant ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Secondary Outcomes ◽  
Maximal Medical Therapy

Abstract Background Severe and fulminant Clostridioides Difficile infection(CDI) is associated with increased mortality and morbidity. Current guidelines recommend high dose vancomycin with metronidazole for treatment. Surgery is a high risk for patients failing medical therapy partly due to multiple comorbidities. Emerging evidence suggests efficacy of sequential fecal microbiota transplantation(FMT) by colonoscopy combined with vancomycin in patients failing maximal medical therapy. Fidaxomicin is non-inferior to vancomycin in treating CDI; however, it has not been studied in severe/fulminant cases. It is not known if FMT by enema combined with fidaxomicin is efficacious and safe in this patient population. Aims This single center, prospective, open-label pilot study aimed to determine the efficacy and safety of combined sequential FMT by enema plus fidaxomicin in severe or fulminant CDI not responding to maximal medical therapy. Primary outcome was resolution of diarrhea 2 weeks following final FMT. Secondary outcomes were resolution of diarrhea 8 weeks following final FMT, safety of proposed treatment protocol and colectomy rate. Methods Consecutive patients with severe or fulminant CDI, who fulfilled study inclusion criteria were recruited. Sequential cycles of FMT, administered by enema daily over three days(720cc followed by 360cc and 180cc), plus fidaxomicin 200mg PO BID were given. Clinical symptoms and inflammatory markers were monitored during the study and subsequent cycles of FMT were administered when clinical or biochemical improvement plateaued. A final FMT was administered with CDI resolution. Results A total of three patients were enrolled between Jan 22 to Aug 8, 2019, shown in Table 1. One patient had fulminant CDI due to shock, and the others had severe CDI. All had severe pseudomembranous colitis seen on endoscopy at enrollment. Two of three patients reached both primary and secondary outcomes with 2 FMT cycles. The only patient who did not reach the primary was successfully managed with long term vancomycin suppression. This patient had failed multiple FMTs prior to enrollment. There were no adverse events noted and no colectomy was required during this study. Conclusions This pilot study is the first to demonstrate efficacy and safety of combined sequential FMT by enema and fidaxomicin in treating severe or fulminant CDI patients. An adequately powered study is required to validate these findings. Funding Agencies CIHRAlberta Health Services, University of Alberta Hospital Foundation

Fecal Microbiota Transplant to Treat Recurrent Clostridium difficile Infections

2015 ◽  
Vol 35 (2) ◽  
pp. 51-64 ◽  
Author(s):  
Miriam L. Boyle ◽  
Lisa A. Ruth-Sahd ◽  
Zehao Zhou
Keyword(s):  
Critical Care ◽  
Clostridium Difficile ◽  
Alternative Treatment ◽  
Treatment Guidelines ◽  
Standard Of Care ◽  
Fecal Microbiota ◽  
Critical Care Nurses ◽  
Great Promise ◽  
Fecal Microbiota Transplant ◽  
Efficient Treatment

The prevalence of recurrent or refractory Clostridium difficile infection has been steadily increasing since 2000. Consequently, alternative treatments to the standard antibiotic therapies are now being considered. One alternative treatment is fecal microbiota transplant. Although fecal microbiota transplant is relatively new—and not appealing to most people—it has been around for many years and has great promise as an inexpensive, safe, and efficient treatment of refractory and recurrent C difficile infection. With a better understanding of the intricacies of the colonic microbiome and its role in colonic physiology and pathophysiology, critical care nurses will recognize that fecal microbiota transplant has the potential to become the standard of care for treatment of recurrent or refractory C difficile infection. The American College of Gastroenterology and the Infectious Diseases Society of America provide the latest treatment guidelines for care of patients with these clostridial infections.

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.

Clostridium difficile: Antikörpertherapie und Impfungen

2019 ◽  
Vol 144 (12) ◽  
pp. 842-849 ◽  
Author(s):  
Emil Christian Reisinger ◽  
Meinolf Ebbers ◽  
Micha Löbermann
Keyword(s):  
Clinical Trials ◽  
Clostridium Difficile ◽  
Fecal Microbiota ◽  
Preventive Strategies ◽  
Efficacy And Safety ◽  
Fecal Microbiota Transplant ◽  
Toxin B ◽  
Vaccine Candidates ◽  
Hospital Acquired ◽  
Risk Of Relapse

AbstractHospital-acquired Clostridium difficile infections have become much more frequent in recent years. Besides treatment with antibiotics and fecal microbiota transplant, new preventive strategies are available now. Bezlotoxumab is an antibody against toxin B and may reduce the risk of relapse by roughly 10 %. Several vaccine candidates against toxins A and B and surface-associated antigens were immunogenic and are tested in clinical trials to investigate the efficacy and safety.

scholarly journals A Systematic Review of Fecal Microbiota Transplant for the Management of Pouchitis

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Maia Kayal ◽  
Thomas Lambin ◽  
Rachel Pinotti ◽  
Marla C Dubinsky ◽  
Ari Grinspan
Keyword(s):  
Systematic Review ◽  
Clinical Response ◽  
Activity Index ◽  
Fecal Microbiota ◽  
Quality Data ◽  
Total Proctocolectomy ◽  
Rrna Gene ◽  
Efficacy And Safety ◽  
Fecal Microbiota Transplant ◽  
Promising Therapeutic Approach

Abstract Background Manipulation of the pouch microbiota via fecal microbiota transplant (FMT) has been theorized to be a promising therapeutic approach for pouchitis. The goal of this systematic review was to summarize the available, high-quality data on the efficacy and safety of FMT for acute and chronic pouchitis. Methods A systematic electronic literature search was conducted on Embase, MEDLINE, Scopus, and Cochrane CENTRAL. Randomized controlled trials and observational studies that assessed the efficacy and safety of FMT for the treatment of acute and/or chronic pouchitis in patients with ulcerative colitis who underwent total proctocolectomy with ileal pouch-anal anastomosis were included. Results Four studies involving the use of FMT for chronic pouchitis were considered eligible for data extraction. No study involving the use of FMT for the management of acute pouchitis was identified. In 1 study, 3/5 (75%) patients achieved sustained clinical remission at 3 months. In the remaining 3 studies, 2/8, 1/11, and 1/5 patients achieved clinical response defined as a decrease in pouchitis disease activity index at least 3. Stool donor engraftment as determined by 16s rRNA gene sequencing occurred only in those patients with clinical response. Conclusions The 4 studies that met inclusion criteria for this systematic review indicate FMT is safe in chronic pouchitis, however largely not efficacious. These data are limited by study heterogeneity. Additional studies are required to guide the use of FMT in patients with acute and chronic pouchitis.

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