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

Author(s):  
Haiming Fang ◽  
Lian Fu ◽  
Xuejun Li ◽  
Jiajia Wang ◽  
Kangwei Xiong ◽  
...  

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

2021 ◽  
Author(s):  
Pratyusha Gaonkar

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.


2021 ◽  
Vol 12 ◽  
Author(s):  
Rongrong Ren ◽  
Xuefeng Gao ◽  
Yichao Shi ◽  
Jianfeng Li ◽  
Lihua Peng ◽  
...  

Aims: To assess the long-term efficacy and safety of single-donor, low-intensity fecal microbiota transplantation (FMT) in treating ulcerative colitis (UC), and to identify the outcome-specific gut bacteria.Design: Thirty-one patients with active UC (Mayo scores ≥ 3) were recruited, and all received FMT twice, at the start of the study and 2∼3 months later, respectively, with a single donor and a long-term follow-up. The fecal microbiome profile was accessed via 16S rRNA sequencing before and after FMT.Results: After the first FMT, 22.58% (7/31) of patients achieved clinical remission and endoscopy remission, with the clinical response rate of 67.74% (21/31), which increased to 55% (11/20) and 80% (16/20), respectively, after the second FMT. No serious adverse events occurred in all patients. During 4 years of follow-up, the mean remission period of patients was 26.5 ± 19.98 m; the relapse rate in the 12 remission patients was 33.33% within 1 year, and 58.3% within 4 years. At baseline, UC patients showed an enrichment in some proinflammatory microorganisms compared to the donor, such as Bacteroides fragilis, Clostridium difficile, and Ruminococcus gnavus, and showed reduced amounts of short-chain fatty acid (SCFA) producing bacteria especially Faecalibacterium prausnitzii. FMT induced taxonomic compositional changes in the recipient gut microbiota, resulting in a donor-like state. Given this specific donor, UC recipients with different outcomes showed distinct gut microbial features before and after FMT. In prior to FMT, relapse was characterized by higher abundances of Bacteroides fragilis and Lachnospiraceae incertae sedis, together with lower abundances of Bacteroides massiliensis, Roseburia, and Ruminococcus; Prevotella copri was more abundant in the non-responders (NR); and the patients with sustained remission (SR) had a higher abundance of Bifidobacterium breve. After FMT, the NR patients had a lower level of Bifidobacterium compared to those with relapse (Rel) and SR, while a higher level of Bacteroides spp. was observed in the Rel group.Conclusion: Low-intensity single donor FMT could induce long remission in active UC. The gut microbiota composition in UC patients at baseline may be predictive of therapeutic response to FMT.


2015 ◽  
Vol 148 (4) ◽  
pp. S-726 ◽  
Author(s):  
Sahil Khanna ◽  
Renee M. Weatherly ◽  
Patricia P. Kammer ◽  
Edward V. Loftus ◽  
Darrell S. Pardi

2021 ◽  
Vol 9 (3) ◽  
pp. 548
Author(s):  
R. E. Ooijevaar ◽  
E. van Nood ◽  
A. Goorhuis ◽  
E. M. Terveer ◽  
J. van Prehn ◽  
...  

Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.


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