Safety Of Fecal Microbiota Transplantation Research Articles

Fecal microbiota transplantation for patients with irritable bowel syndrome: A meta-analysis protocol.

Irritable bowel syndrome (IBS) is a common functional bowel disease characterized by chronic or recurrent abdominal pain, bloating, constipation, and diarrhea. Many patients with IBS have a poor quality of life due to abdominal discomfort, diarrhea, constipation, and the presence of other diseases. At present, intestinal motility inhibitors, adsorbents, astringents, intestinal mucosal protective agents, and antidepressants have been combined to treat IBS, but the treatment process is long, which results in a large economic burden to patients. Fecal microbiota transplantation (FMT) is a treatment involving the transplantation of functional bacteria from healthy human feces into the gastrointestinal tract of patients; thus, replacing the intestinal flora and modulating intestinal and extra-intestinal diseases. In recent years, the efficacy and economic benefits of FMT in the treatment of IBS have received increasing attention from researchers.A search for randomized controlled trials (RCTs) on treating IBS with FMT will be performed using 9 databases, including PubMed, the Cochrane Library, Embase, ClinicalTrails, China National Knowledge Infrastructure, Sino Med, ScienceDirect, VIP, and Wanfang Data. Two reviewers will independently screen data extraction studies and assess study quality and risk of bias. The risk of bias for each RCT will be assessed against the Cochrane Handbook standards to assess methodological quality. RevMan V.5.3 software will be used to calculate data synthesis when meta-analysis is allowed.This study will provide a high-quality synthesis of existing evidence on the effectiveness and safety of FMT in the treatment of IBS.This study will determine if FMT is an effective and safe intervention for IBS.PROSPERO registration number is PROSPERO CRD42018108080.

Treating Steroid Refractory Intestinal Acute Graft-vs.-Host Disease With Fecal Microbiota Transplantation: A Pilot Study.

Patients with steroid refractory gastrointestinal (GI) tract graft- vs.-host disease (GvHD) face a poor prognosis and limited therapeutic options. To accurately assess the efficacy and safety of fecal microbiota transplantation (FMT) in treating steroid refractory GI tract GvHD, we conducted a pilot study involving eight patients. Having received FMTs, all patients' clinical symptoms relieved, bacteria enriched, and microbiota composition reconstructed. Compared to those who did not receive FMT, these eight patients achieved a higher progression-free survival. FMT can serve as a therapeutic option for GI tract aGVHD, but its effectiveness and safety need further evaluations.Clinical Trial Registration: NCT03148743.

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

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.

2092 A multicenter study of fecal microbiota transplantation for Clostridium difficile infection in children

OBJECTIVES/SPECIFIC AIMS: Clostridium difficile infection (CDI) is the most common cause of antibiotic-associated diarrhea and an increasingly common infection in children in both hospital and community settings. Between 20% and 30% of pediatric patients will have a recurrence of symptoms in the days to weeks following an initial infection. Multiple recurrences have been successfully treated with fecal microbiota transplantation (FMT), though the body of evidence in pediatric patients is limited primarily to case reports and case series. The goal of our study was to better understand practices, success, and safety of FMT in children as well as identify risk factors associated with a failed FMT in our pediatric patients. METHODS/STUDY POPULATION: This multicenter retrospective analysis included 373 patients who underwent FMT for CDI between January 1, 2006 and January 1, 2017 from 18 pediatric centers. Demographics, baseline characteristics, FMT practices, C. difficile outcomes, and post-FMT complications were collected through chart abstraction. Successful FMT was defined as no recurrence of CDI within 60 days after FMT. Of the 373 patients in the cohort, 342 had known outcome data at two months post-FMT and were included in the primary analysis evaluating risk factors for recurrence post-FMT. An additional six patients who underwent FMT for refractory CDI were excluded from the primary analysis. Unadjusted analysis was performed using Wilcoxon rank-sum test, Pearson χ2 test, or Fisher exact test where appropriate. Stepwise logistic regression was utilized to determine independent predictors of success. RESULTS/ANTICIPATED RESULTS: The median age of included patients was 10 years (IQR; 3.0, 15.0) and 50% of patients were female. The majority of the cohort was White (89.0%). Comorbidities included 120 patients with inflammatory bowel disease (IBD) and 14 patients who had undergone a solid organ or stem cell transplantation. Of the 336 patients with known outcomes at two months, 272 (81%) had a successful outcome. In the 64 (19%) patients that did have a recurrence, 35 underwent repeat FMT which was successful in 20 of the 35 (57%). The overall success rate of FMT in preventing further episodes of CDI in the cohort with known outcome data was 87%. Unadjusted predictors of a primary FMT response are summarized. Based on stepwise logistic regression modeling, the use of fresh stool, FMT delivery via colonoscopy, the lack of a feeding tube, and a lower number of CDI episodes before undergoing FMT were independently associated with a successful outcome. There were 20 adverse events in the cohort assessed to be related to FMT, 6 of which were felt to be severe. There were no deaths assessed to be related to FMT in the cohort. DISCUSSION/SIGNIFICANCE OF IMPACT: The overall success of FMT in pediatric patients with recurrent or severe CDI is 81% after a single FMT. Children without a feeding tube, who receive an early FMT, FMT with fresh stool, or FMT via colonoscopy are less likely to have a recurrence of CDI in the 2 months following FMT. This is the first large study of FMT for CDI in a pediatric cohort. These findings, if confirmed by additional prospective studies, will support alterations in the practice of FMT in children.

Efficacy and safety of faecal microbiota transplantation in patients with psoriatic arthritis: protocol for a 6-month, double-blind, randomised, placebo-controlled trial

IntroductionAn unbalanced intestinal microbiota may mediate activation of the inflammatory pathways seen in psoriatic arthritis (PsA). A randomised, placebo-controlled trial of faecal microbiota transplantation (FMT) infused into the small intestine...

Fecal microbiota transplantation in refractory or recurrent Clostridium difficile infection: a real-life experience in a non-academic center.

this study aimed to describe the efficacy and safety of fecal microbiota transplantation (FMT) for the treatment of refractory and recurrent Clostridium difficile infection (CDI). this was an observational study of patients with refractory or recurrent CDI treated with FMT between June 2014 and January 2017. Primary and secondary outcomes were the resolution of diarrhea without CDI recurrence within two months after one or more FMT. A descriptive analysis was performed. thirty-four FMT were performed in 28 patients, 88.2% (n = 30) using an upper route with a gastroscopy and 11.8% (n = 4) with colonoscopy; 50% (n = 17) of FMT were due to recurrent CDI and 50% (n = 17) were due to refractory CDI. The overall cure rate of upper FMT was 87.5% (21/24) and 100% (4/4) when colonoscopy was performed. A cure was achieved after one FMT in 88% (22/25) of cases and after two or more FMT in 8% (2/25) of cases, resulting in an overall cure rate of 96% (24/25). No severe adverse events were reported. FMT constitutes an effective and safe approach for the management of refractory and recurrent CDI, with an overall cure rate of 96% and no reported severe adverse events.

Clinical Utility and Safety of Fecal Microbiota Transplantation to Children with Refractory Ulcerative Colitis

Clinical Utility and Safety of Fecal Microbiota Transplantation to Children with Refractory Ulcerative Colitis

Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders

Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI. Numerous case reports, retrospective case series, and randomized controlled trials have shown the benefit of FMT in patients with functional bowel disorders, including inflammatory bowel disease, irritable bowel syndrome and constipation, etc. Evidence regarding the safety of FMT is relatively limited because the very rapid adoption of FMT as a therapeutic modality for CDI occurred before the performance of large, long prospective trials that are typically conducted to assess the safety of new interventions. Potential adverse events can be categorized as short-term and long-term, and short-term events can further be divided into those related to the method of FMT delivery (colonoscopy, sedation) and those related to the FMT itself. Due to the recent emergence of FMT, little data exist regarding long-term events and many safety concerns are speculative. Capsulized FMT therapy solves the clinical problems associated with the use of fresh FMT suspensions for long-term maintenance i.e. repeat transplantation and invasive procedures, which is of great significance to optimize the traditional FMT clinical strategy. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current "whole-stool" transplants to increase safety and tolerability. Encapsulated formulations, full-spectrum stool-based products, and defined microbial consortia are all in the immediate future. Although challenges exist, regulatory agencies have been willing to work with stakeholders and will continue to evolve and adapt policy as therapeutics based on human gut microbiota research emerge.

Efficacy of Fecal Microbiota Transplant (FMT) In Severe/Complicated Clostridium difficile Infection (CDI): A Case Series

Introduction: There is significant data that establishes the efficacy and safety of Fecal Microbiota Transplant (FMT) in recurrent Clostridium difficile infection (CDI), however there is limited data on the success of FMT in severe/complicated CDI. We describe a case series of 4 patients at our tertiary care center who underwent FMT in the ICU for fulminant CDI refractory to antimicrobial therapy. Case Description: Our study cohort included 2 Caucasian,1 African American and 1 Indian patient. All 4 of them were admitted to the ICU for complicated CDI. 2 of these patients were in septic shock from CDI colitis. 1 had end organ failure with AKI requiring dialysis and the other had severe sepsis with respiratory failure. CDI was confirmed by stool PCR.? All 4 patients were on antibiotics for CDI with intravenous Metronidazole and oral Vancomycin.Two patients also received Vancomycin enema and 1 patient was on Fidaxomicin.In each case, CDI was refractory to treatment with adequate antibiotic therapy with unchanged/worsening clinical status. Therefore, FMT was considered as the next step. The donor stool was obtained from Open Biome. 3 of them underwent FMT via NG Tube consisting of 100 cc of slurry. One patient received FMT via PEG tube .After FMT, 2 of them were continued on oral Vancomycin; 1 patient continued both IV Metronidazole and oral Vancomycin. Antibiotics were discontinued on one patient.?After FMT, all 4 had resolution of symptoms with marked improvement of diarrhea and abdominal pain. The average time interval between FMT and improvement of symptoms was 5.25 days (2-8). One patient had recurrent CDI after 3 months which was attributed to the use of antibiotics for COPD.Table: No Caption availableDiscussion: Severe/complicated CDI is defined by the 2013 ACG guidelines as: admission to ICU for CDI, hypotension with or without use of vasopressors, fever ≥38.5 °C, ileus, significant abdominal distention, WBC ≥ 35 000 cells/mm3, lactate levels >2.2 mmol/L or end organ failure.Complicated CDI is challenging often requiring prolonged ICU stay. Colectomy is the standard of care in severe cases; however mortality rates are as high as 35-57 %.Often many patients are poor surgical candidates due to significant comorbidities such as shock, respiratory failure and advanced age> 80. Our success with FMT in the critically ill suggests that FMT should be considered judiciously earlier in the disease course for early symptoms resolution and avoidance of the more invasive colectomy.

The Current Landscape and Lessons from Fecal Microbiota Transplantation for Inflammatory Bowel Disease: Past, Present, and Future.

Fecal microbiota transplantation (FMT) has changed the standard of care for Clostridium difficile infection. However, there is limited data focusing on efficacy and safety profile of FMT in patients with C. difficile infection with underlying inflammatory bowel disease (IBD), including the risk of IBD flare. Recently, there is also emerging evidence supporting the role of FMT to treat IBD including promising randomized trials in ulcerative colitis. However, with heterogeneity across these studies, the clinical application of this emerging therapy has yet to be fully elucidated. Here, we aim to review the current landscape of this rapidly developing field, mapping the efficacy and safety of FMT (1) to treat C. difficile infection in patients with IBD, (2) to treat underlying IBD, and (3) outline ongoing clinical trials and the future of the microbiome space.

Multiple fresh fecal microbiota transplants induces and maintains clinical remission in Crohn\u2019s disease complicated with inflammatory mass

The ancient Chinese medical literature, as well as our prior clinical experience, suggests that fecal microbiota transplantation (FMT) could treat the inflammatory mass. We aimed to evaluate the efficacy and safety of multiple fresh FMTs for Crohn’s disease (CD) complicated with intraabdominal inflammatory mass. The "one-hour FMT protocol" was followed in all patients. Twenty-five patients were diagnosed with CD and related inflammatory mass by CT or MRI. All patients received the initial FMT followed by repeated FMTs every 3 months. The primary endpoint was clinical response (improvement and remission) and sustained clinical remission at 12 months. Secondary endpoints were improvement in size of phegmon/abscess based upon cross-sectional imaging and safety of FMT. 68.0% (17/25) and 52.0% (13/25) of patients achieved clinical response and clinical remission at 3 months post the initial FMT, respectively. The proportion of patients at 6 months, 12 months and 18 months achieving sustained clinical remission with sequential FMTs was 48.0% (12/25), 32.0% (8/25) and 22.7% (5/22), respectively. 9.5% (2/21) of patients achieved radiological healing and 71.4% (15/21) achieved radiological improvement. No severe adverse events related to FMT were observed. This pragmatic study suggested that sequential fresh FMTs might be a promising, safe and effective therapy to induce and maintain clinical remission in CD with intraabdominal inflammatory mass.

P589 Faecal microbiota transplantation for inflammatory bowel disease: a systematic review and meta-analysis

Background: Given the importance of the enteric microbiota in the pathogenesis of the inflammatory bowel diseases, faecal microbiota transplantation (FMT) has been advocated as a potential therapeutic strategy, and has been the recent subject of increasing research. We thus performed a systematic review and meta-analysis to assess the effectiveness and safety of FMT in the treatment of inflammatory bowel diseases. Methods: A systematic review of the literature was conducted up until the end of March 2016 in accordance with PRISMA and Cochrane recommendations. Electronic databases were searched, along with hand searching of major conference proceedings. Studies were excluded if patients had co-infection or if data was pooled across disease subtypes (ulcerative colitis (UC), Crohn's disease (CD), pouchitis) and could not be individually extracted. Clinical remission was established as the primary outcome; clinical response, endoscopic remission and safety were secondary outcomes. Pooled effect sizes and 95% confidence intervals were obtained using the random effects model. Heterogeneity, sensitivity and subgroup analyses were also performed. Results: 5940 records were identified of which 82 articles were reviewed. Thirty eight studies were included (29 in UC [including 3 randomised controlled trials], 11 in CD, 3 in pouchitis) reporting on 371 UC, 73 CD and 22 pouchitis patients. Overall, 37.5% (139/371) of UC patients, 49.5% (36/73) of CD patients and 18% (4/22) of pouchitis patients achieved clinical remission during follow-up. Among the cohort studies, the pooled proportion of patients that achieved clinical remission was 33% (95% CI 24%– 44%) for UC with a moderate risk of heterogeneity (Cochran's Q, p=0.121; I2 =31%) and 53% (95% CI 30%– 75%) for CD with a moderate risk of heterogeneity (Cochran's Q, p=0.081; I2 =49%). For the 3 RCTs of FMT in UC, there was borderline benefit in clinical remission (P-OR =2.37, 95% CI =0.91–6.19, p=0.078) with moderate heterogeneity (Cochran's Q, p=0.168; I2 =44%). The controlled trial and cohort data suggest remission in UC is improved with increased number of FMT infusions and administration via the lower gastrointestinal tract. Most adverse events were transient minor gastrointestinal complaints. Microbiota analysis was performed in 16 studies, with many identifying a shift in recipient microbiota profile towards that of the donor post FMT. Conclusions: There is a need for additional well designed controlled studies of FMT in IBD, especially in CD and pouchitis. FMT appears to be effective in the induction treatment of UC, particularly with increasing number of infusions. Long term durability and safety remain unclear.

Functional amplification and preservation of human gut microbiota.

ABSTRACT Background: The availability of fresh stool samples is a prerequisite in most gut microbiota functional studies. Objective: Strategies for amplification and long-term gut microbiota preservation from fecal samples would favor sample sharing, help comparisons and reproducibility over time and between laboratories, and improve the safety and ethical issues surrounding fecal microbiota transplantations. Design: Taking advantage of in vitro gut-simulating systems, we amplified the microbial repertoire of a fresh fecal sample and assessed the viability and resuscitation of microbes after preservation with some common intracellular and extracellular acting cryoprotective agents (CPAs), alone and in different combinations. Preservation efficiencies were determined after 3 and 6 months and compared with the fresh initial microbiota diversity and metabolic activity, using the chemostat-based Environmental Control System for Intestinal Microbiota (ECSIM) in vitro model of the gut environment. Microbial populations were tested for fermentation gas, short-chain fatty acids, and composition of amplified and resuscitated microbiota, encompassing methanogenic archaea. Results: Amplification of the microbial repertoire from a fresh fecal sample was achieved with high fidelity. Dimethylsulfoxide, alone or mixed with other CPAs, showed the best efficiency for functional preservation, and the duration of preservation had little effect. Conclusions: The amplification and resuscitation of fecal microbiota can be performed using specialized in vitro gut models. Correct amplification of the initial microbes should ease the sharing of clinical samples and improve the safety of fecal microbiota transplantation. Abbreviations: CDI, Clostridium difficile infection; CPA, cryoprotective agent; D, DMSO, dimethylsulfoxide; FMT, fecal microbiota transplantation; G, glycerol; IBD, inflammatory bowel disease; P, PEG-4000, polyethylene glycol 4000 g.mol−1; SCFA, short-chain fatty acid; SNR, signal-to-noise ratio

Clinical Effectiveness and Safety of Fecal Microbiota Transplantation in Children for Clostridium Difficile infection: Results from 9 Pediatric Centers in the United States: 2016 ACG Presidential Poster Award

Introduction:Clostridium difficile infection (CDI) is a major public health threat and a rising concern among the pediatric population. Fecal microbiota transplantation (FMT) is a cost-effective therapy for recurrent CDI and universal stool banks have emerged to enable safe and seamless access. Although FMT has been reported among children in small case series, a direct donor (e.g. parent) approach has primarily been employed. Accordingly, there is a paucity of pediatric safety and effectiveness data from stool banks. Methods: Quality assurance data on CDI classification, FMT delivery modality and clinical effectiveness was consecutively collected from 9 pediatric healthcare facilities in the United States between January 16, 2014 and June 1, 2016. Patients were treated with 250mL fecal microbiota preparation (FMP) for lower GI delivery or 30mL FMP for upper GI delivery. The primary outcome was physician-reported clinical cure as per standard of care follow-up. Safety data was assessed through mandatory adverse event (AE) reporting and graded according to NIH criteria. Descriptive statistics and Chi-square analysis for binomial variables was conducted. Results: Among consecutively collected reports, complete safety and effectiveness data was returned for 69 patients, which were included in these analyses. Overall, the clinical cure rate from physician-reported data across all delivery modalities and CDI classifications was 85.5%. Across the pediatric cohort, 69.6% (n=48) of patients were treated by lower GI delivery by colonoscopy (n=46) or enema (n=2) with a cure rate of 80.9%. Additionally, 30.4% (n=21) of the cohort was treated by upper GI delivery by nasogastric (n=11), nasoduodenal (n=1), nasojejunal (n=2) and EGD (n=7) with a clinical cure rate of of 87.5%. There was no statistically significant difference in clinical cure between lower and upper GI delivery (p=0.47). Specifically, clinical cure for colonoscopy (85.4%) and nasogastric delivery (85.1%) was not significantly different (p=0.99). On a priori subgroup analysis, there was no significant difference in clinical cure rate by CDI disease classification and FMP preparation type (Table 1). No adverse events were reported to OpenBiome.Figure 1Conclusion: To our knowledge this is the largest pediatric FMT cohort reported to date. This real-world clinical data suggests that FMT in pediatric CDI has a similar safety and effectiveness profile to FMT in adult CDI. Further long-term follow-up is required to evaluate the long-term safety profile.

Submitted, Not Presented: Inflammatory Bowel Disease.

Introduction: Steroid dependance develops in 15- 20% of patients of ulcerative colitis. These patients are prone to develop various side effects of long term steroid abuse. Medical treatment options in such cases, biologicals and/or immunosuppressive are expensive and associated with significant toxicity. Recently, there have been reports of FMT being effective in some of these patients. We evaluated the efficacy and safety of fecal microbiota transplantation(FMT) in patients with steroid dependant ulcerative colitis Methods: We report the data of an open label study of FMT in induction and maintainance of remission of patients with steroid dependant ulcerative colitis. Baseline demographic disease characteristics, disease severity and drug history at enrollment were recorded. FMT protocol was 2 weekly for 2 times and then 4 weekly for 5 times (a total of 7 sessions). Clinical and endoscopic response was assessed using mayo score at week 4, end of study period (6 months) and follow up of 6 months.Figure 1Figure 2Results: A total of 17 patients were enrolled. Of these, 10 were males and mean age for the whole group was 35.23 years (23-55). Seven patients (41.1%) had pancolitis and 10 (58.8%) had left sided disease. All patients (n = 17) had moderate to severe disease. Fifteen of 17 (88.23 %) patients achieved clinical remission at week 4. Ten (58.8 %) stayed in remission at the end of 6 months of treatment and 6 months follow up period, allowing stoppage of steroids. Five (29.4 %) patients who initially responded to FMT, eventually had worsening of symptoms and were given adalimumab. Of the remaining 2 patients, 1 (5.8 %) was lost to follow up after a single session of FMT, while the other (5.8 %) developed toxic megacolon after 2 sessions, then post operative sepsis and died. Conclusion: FMT is a promising therapeutic option for patients having steroid dependant ulcerative colitis. Previous exposure to immunosuppressives or biologicals does not hamper response to FMT. However, Randomized, placebo controlled trials from developing countries are needed for more robust data.

Fecal Microbiota Transplantation for Treatment of Severe, Recurrent, and Refractory Clostridium difficile Infection in a Severely Immunocompromised Patient

Abstract Information on the safety of fecal microbiota transplantation (FMT) among immunocompromised patients with Clostridium difficile infection (CDI) is limited, and some have recommended avoiding FMT in this population. We report a case of severe, refractory CDI in an orthotopic heart transplant recipient with pre-existing CD4 lymphopenia. Our experience suggests that FMT can be safe and effective in treating CDI in immunocompromised patients with acute illness.

Fecal Microbiota Transplantation for Ulcerative Colitis: A Systematic Review and Meta-Analysis.

BackgroundFecal microbiota transplantation (FMT) has been recognized as a novel treatment for ulcerative colitis (UC). However, its efficacy and safety remain unclear.ObjectiveWe conducted this systematic review to assess the efficacy and safety of FMT in UC.Data SourcesPubMed, EMBASE, Cochrane Central, Web of Science Core Collection, and three other Chinese databases were searched for reports of FMT in UC with clear outcomes.Data Extraction and SynthesisWe estimated pooled rates [with 95% confidence interval (CI)] of clinical remission among 15 cohort studies and clinical response among 16 cohort studies.ResultsTwenty five studies (2 randomized controlled trials, 15 cohort studies, and 8 case studies) with 234 UC patients were included. Overall, 41.58% (84/202) patients achieved clinical remission (CR) and 65.28% (126/193) achieved clinical response. Among the cohort studies, the pooled estimate of patients who achieved CR and clinical response were 40.5% (95% CI 24.7%-58.7%), and 66.1% (95% CI 43.7%-83.0%). Most adverse events were slight and self-resolving. The analyses of gut microbiota in 7 studies showed that FMT could increase microbiota diversity and richness, similarity, and certain change of bacterial composition.ConclusionFMT provides a promising effect for UC with few adverse events. Successful FMT may be associated with an increase in microbiota diversity and richness, similarity, and certain change of bacterial composition.

Fecal Microbiota Transplantation as a Novel Therapy for Ulcerative Colitis: A Systematic Review and Meta-Analysis.

Variation in clinical evidence has prevented the adoption of fecal microbiota transplantation (FMT) in patients with ulcerative colitis (UC). We aimed to conduct a systematic review and meta-analysis to determine the efficacy and safety of FMT in UC.A systematic literature search was performed in 5 electronic databases from inception through September 2015. Inclusion criteria were reports of FMT in patients with UC. Studies were excluded if they did not report clinical outcomes or included patients with infections. Clinical remission (CR) was defined as the primary outcome.Eleven studies (2 randomized controlled trials (RCTs), 1 open-label case-control study, and 8 cohort studies) with a total of 133 UC patients were included in the analysis. In 11 studies (including 8 noncontrol cohort studies and the treatment arms of 3 clinical control trials), the pooled proportion of patients who achieved CR was 30.4% (95% CI 22.6–39.4%), with a low risk of heterogeneity (Cochran Q test, P = 0.139; I2 = 33%). A subgroup analysis suggested that no difference in CR was detected between upper gastrointestinal delivery versus lower gastrointestinal delivery. Furthermore, subgroup analysis revealed that there was no difference in CR between single infusion versus multiple infusions (>1) of FMT. All studies reported mild adverse events.FMT is potentially useful in UC disease management but better-designed RCTs are still required to confirm our findings before wide adoption of FMT is suggested. Additionally, basic guidelines are needed imminently to identify the right patient population and to standardize the process of FMT.

Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives.

Fecal microbiota transplantation (FMT) is the infusion of liquid filtrate feces from a healthy donor into the gut of a recipient to cure a specific disease. A fecal suspension can be administered by nasogastric or nasoduodenal tube, colonoscope, enema, or capsule. The high success rate and safety in the short term reported for recurrent Clostridium difficile infection has elevated FMT as an emerging treatment for a wide range of disorders, including Parkinson’s disease, fibromyalgia, chronic fatigue syndrome, myoclonus dystopia, multiple sclerosis, obesity, insulin resistance, metabolic syndrome, and autism. There are many unanswered questions regarding FMT, including donor selection and screening, standardized protocols, long-term safety, and regulatory issues. This article reviews the efficacy and safety of FMT used in treating a variety of diseases, methodology, criteria for donor selection and screening, and various concerns regarding FMT.

Fecal microbiota transplant for Clostridium difficile infection in older adults.

The objective of this study was to describe the safety of fecal microbiota transplant (FMT) for Clostridium difficile infection (CDI) among older adults. We performed a case review of all FMT recipients aged 65 or older treated at Emory University Hospital, a tertiary care and referral center for Georgia and surrounding states. CDI resolved in 27 (87%) of 31 respondents, including three individuals who received multiple FMTs. Among four whose CDI was not resolved at follow up, three respondents did well initially before CDI recurred, and one individual never eradicated his CDI despite repeating FMT. During the study, five deaths and eight serious adverse events requiring hospitalization were reported within the study group during the follow-up period. Fecal transplant was not a causative factor in these events. The most common adverse event reported in 4 (13%) of 31 respondents was subjective worsening of arthritis. FMT is a generally safe and effective treatment option for older adults with CDI.