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 Long-term efficacy and safety of single fecal microbiota transplantation for recurrent active ulcerative colitis

2020 ◽  
Author(s):  
Haiming Fang ◽  
Lian Fu ◽  
Xuejun Li ◽  
Jiajia Wang ◽  
Kangwei Xiong ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Relative Abundance ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Efficacy And Safety ◽  
Long Term Follow Up ◽  
Initial Responder

AbstractAimsTo assess the long-term safety and efficacy of single fecal microbiota transplantation (FMT) for recurrent ulcerative colitis (UC).Methods20 UC patients were randomly divided into single FMT (n=10) and standard of care (SOC) (n=10) group. Patients in FMT group were just treated with single fresh FMT. Patients in SOC group with mild to moderate UC were treated with mesalazine, those with severe UC were given corticosteroids-induced remission, mesalazine maintenance treatment. The primary endpoint was clinical and mucosal remission at week 8. The second endpoint was the maintenance of clinical and mucosal remission, and possible adverse events during the long term follow up (12 to 24 months).Results90% (9/10) patients in FMT group and50% (5 /10)in SOC group could achieve primary endpoint at week-8.After 12 months of follow-up, 66.7% (6/9) FMT initial responder and 80.0% (4/5) SOC initial responder could maintain remission.5 FMT initial responder recipients and5SOC initial responder completed 24-months follow up and mainly could maintain remission [FMT vs SOC580% (4/5) vs 60% (3/5)].No adverse events occurred post FMT during long-term follow-up. At Phylum level, Bacteroidetes, Firmicutes and Proteobacteria were the dominant bacteria of gut microbiota in active UC patients. Compared with donor, the relative abundance of Bacteroidetes decreased and Proteobacteria increased significantly in active UC patients, Firmicutes showed no significant changes. Single fresh FMT could effectively reconstruct the composition of gut microbiota in active UC and maintain stability level with increased Bacteroidetes and decreased Proteobacteria abundance. FMT significantly reduced the relative abundance of Escherichia and increased the relative abundance of Prevotella at genera level. Pyruvate metabolism, glyoxylate and dicarboxylate metabolism, pantothenate and CoA biosynthesis showed significantly differences.ConclusionsSingle fresh FMT is an effective and safe strategy to induce long-term remission in patients with active UC and could be expected to be an alternative induction therapy for recurrent UC, even primary UC.What does this paper add to the literature?FMT is an effective and safe therapy for UC. However, long-term efficacy and safety of a single FMT was very limited. The present study found that a single fresh FMT could induce long-term remission in UC with no drugs need and could be expected to be an alternative induction therapy for recurrent UC, even primary UC

scholarly journals Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register

2008 ◽  
Vol 68 (5) ◽  
pp. 635-641 ◽  
Author(s):  
F H M Prince ◽  
M Twilt ◽  
R ten Cate ◽  
M A J van Rossum ◽  
W Armbrust ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Adverse Events ◽  
Rheumatoid Factor ◽  
Serious Adverse Events ◽  
American College Of Rheumatology ◽  
Systemic Jia ◽  
Long Term Follow Up ◽  
Remission Criteria

Objective:We undertook an observational study to obtain a complete overview of the long-term effectiveness and safety of etanercept in patients with different juvenile idiopathic arthritis (JIA) subtypes.Methods:At baseline we collected patient and disease characteristics of all Dutch patients with JIA who started treatment with etanercept. Disease activity was evaluated (at start of the study, after 3 months and then yearly) according to the JIA core set of the American College of Rheumatology paediatric definition for 30, 50 and 70% improvement (ACR Pedi 30, 50 and 70). Use of etanercept and concomitant drugs was monitored. Adverse events were recorded.Results:We included 146 patients with JIA with a median follow-up of 2.5 years per patient (range 0.3–7.3). JIA subtypes represented: 27% systemic, 8% polyarticular rheumatoid factor positive, 38% polyarticular rheumatoid factor negative, 19% oligoarticular extended, 3% enthesitis-related and 5% psoriatica. Most patients (77%) met the criteria of the ACR Pedi 30 in the first 3 months of treatment. For the majority of patients this improvement was sustained; 53 (36%) of all patients met the remission criteria. No other second-line agents were needed in 43 patients. Although patients with systemic JIA responded initially less to etanercept therapy than patients from other subtypes, those who did respond showed equal effectiveness in the long term. Serious adverse events rate was low (0.029 per patient year).Conclusions:Etanercept is effective and safe in JIA, even for a large proportion of the patients with systemic JIA. The greatest improvement occurred in the first 3 months of treatment, and was sustained for a long time in most patients (up to 75 months).

Mo1849 Long-Term Follow-Up After Fecal Microbiota Transplantation for C. difficile Infection in Inflammatory Bowel Disease Patients

2015 ◽  
Vol 148 (4) ◽  
pp. S-726 ◽  
Author(s):  
Sahil Khanna ◽  
Renee M. Weatherly ◽  
Patricia P. Kammer ◽  
Edward V. Loftus ◽  
Darrell S. Pardi
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Long Term Follow Up ◽  
Inflammatory Bowel
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