scholarly journals Fecal Microbiome Transplantation for Recurrent Clostridioides difficile Infection: Treatment Efficacy, Short and Long-term Follow-up Results from Consecutive Case Series

Author(s):  
Tadas Urbonas ◽  
Gianluca Ianiro ◽  
Rolandas Gedgaudas ◽  
Povilas Sabanas ◽  
Mindaugas Urba ◽  
...  

Background and Aims: Many studies have shown a high effectiveness of fecal microbiota transplantation (FMT) in treatment of recurrent or refractory Clostridioides difficile infection (CDI). Nevertheless, data on long term outcomes and complications after FMT are still lacking. We aimed to evaluate the efficacy, the peri- procedural safety profile and the long-term efficacy and safety of FMT for recurrent CDI during a median follow up period of 24 months. Methods: Our study included 60 consecutive patients that were treated from 2015 to 2019 for recurrent CDI. In all patients FMT was performed through the nasoenteric tube placed during gastroscopy. Fresh donor feces were used for FMT from unrelated donors. Pre-FMT preparation included CDI treatment with oral vancomycin 500 mg q.i.d. for at least five days and proton pump inhibitor (PPI) administration before FMT. Follow up data included information about recurrent CDI episodes, early and late complications, health status at 3, 12 and 24 months after FMT. Results: FMT was performed for 60 patients (median age 72.5 years) with recurrent CDI. Clinical improvement after the first FMT procedure was observed in 48 patients (80%). Ten of 12 initially non-responding patients had a clinical resolution after a second FMT leading to an increased overall cure rate of 96.7 %. The remaining two patients needed a third FMT with a final overall cure rate of 100%. Nine of 60 patients were under immunosuppressive therapy. Six immunosuppressed patients were in the group of initial responders and the remaining three in the initially non-responder group. We observed a very low rate of adverse events in the short and long-term after FMT. During the first eight weeks after the FMT procedure, the death of three patients occurred, but they were not related to the FMT procedure. Patients were followed up for a median of 20 months, with the range from 12 to 55 months. During the follow-up period no long-term serious adverse events (SAE) were documented. Conclusions: Our study confirms excellent efficacy rates of FMT in the treatment of recurrent CDI. In addition, this study shows that it is possible to avoid short term SAE when FMT is administered via a nasoenteric tube by following a very stringent peri-procedural patient follow-up protocol. Our study also demonstrates good safety with a low rate of long-term adverse events after FMT.

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.


2022 ◽  
Author(s):  
Feng Yin ◽  
Mingming Zhao ◽  
Xin Yan ◽  
Tong Li ◽  
Hui Chen ◽  
...  

Abstract Subthalamic nucleus (STN) deep brain stimulation (DBS) has been proven to be an alternative target choice for refractory isolated cervical dystonia (CD). However, assessments of its short and long-term safety, efficacy, and sustained effectiveness have been limited to few reports. Here, we evaluated nine consecutive refractory isolated CD patients who underwent bilateral STN DBS and accepted to short and long-term follow-up in this retrospective study. Seven time points were used to see the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores (pre-operation [baseline], 1, 3, 6, 12, 24 months post-operation and last follow-up) to assess improvement of dystonic symptoms. The 36-item Short-Form General Health Survey (SF-36) scores obtained at pre-operation and last follow-up to assess the changes in quality of life. All patients tolerated surgery well and acquired observable clinical benefits from STN DBS therapy. All patients achieved a considerable improvement in quality of life at the last follow-up. The hardware-related adverse events can be tolerated and the stimulation-related adverse events can be ameliorated by programming. Our data support the idea that bilateral STN DBS is a safety and effective method for the treatment of refractory isolated CD, with persistent and remarkable improvement in both movement and quality of life.


2019 ◽  
Vol 10 (3) ◽  
pp. 364-366
Author(s):  
Nicola Pradegan ◽  
Biagio Castaldi ◽  
Danila Azzolina ◽  
Giovanni Stellin ◽  
Vladimiro L. Vida

The aim of this study is to analyze the adaptation properties of the pulmonary autograft in four infants who underwent the Ross operation before one year of life. The patients underwent serial echocardiographic assessments of the autograft diameters at short- and long-term follow-up and values were reported as the Z scores for normal aortic and pulmonary diameters. At a median follow-up time of 18.5 years (range: 18.2-19.4 years), all the patients are alive, none requiring autograft reinterventions. This series shows excellent adaptation potential of the “infant pulmonary autograph” in the long-term, during somatic growth of the patient.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5870-5870
Author(s):  
Raseen Tariq ◽  
Fateeha Furqan ◽  
Saad Jamshed ◽  
Sahil Khanna

Introduction: Fecal microbiota transplant (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection (CDI). Immunosuppression is one of the risk factors for CDI. However, most of the trials evaluating efficacy of FMT have excluded immunocompromised patients. Patients with hematological cancers represent a major class of immunocompromised patients. Hence, we performed a meta-analysis to evaluate the efficacy of FMT in patients with hematological cancer for the treatment of recurrent CDI. Methods: A systematic search of Medline, Embase, and Web of Science was performed from January 2000 up to December 2018. Articles included for meta-analysis were case series and case reports that assessed efficacy of FMT in hematological cancer patients were included. Study quality was assessed using the Newcastle-Ottawa scale. The main outcomes were pooled proportions of patients achieving cure after first FMT. The cure rate was defined as resolution of diarrhea without any recurrence. Results: 10 studies (5 case series and 5 case reports) were included in the analysis, making up 29 patients who underwent 38 total FMT procedures. The follow up period ranged from 1- 14 months. Of the included patients, 17 had leukemia, 10 had lymphoma and 2 patients had multiple myeloma and myelodysplastic syndrome each. 7 of these patients had undergone hematopoietic stem cell transplant. The pooled cure rate was 82% [confidence interval (CI) 67-94%] after 1 FMT with no heterogeneity (I2=0%). Minor publication bias was seen on visual inspection of funnel plot. FMT was generally well tolerated by these patients. No serious side effects were reported in any study. One of the studies reported death due to cardiac arrest 5 days after FMT which was thought to be unrelated to the procedure. Mild side effects including mild abdominal pain, transient diarrhea, fecal urgency, constipation and nausea were reported in 5 patients. Conclusion: Based on limited observational data, FMT seems to be an effective and safe modality for management of recurrent CDI in patients with hematological cancers. However, further prospective clinical trials are needed to establish its safety as a first line therapy for recurrent CDI in this population. Figure Disclosures Jamshed: Takeda Pharmaceutical: Honoraria. Khanna:Rebiotix, Inc: Research Funding; Probio Tech, LLC: Consultancy; Facile Therapeutics: Consultancy; Shire, Plc: Consultancy.


2020 ◽  
Vol 15 (1) ◽  
pp. 4-10
Author(s):  
Aziz Muhammad ◽  
Weissman Simcha ◽  
Fatima Rawish ◽  
Rajani Sabih ◽  
Eid Albert ◽  
...  

Background:: Current guidelines recommend the use of vancomycin for the initial treatment of Clostridioides difficile Infection (CDI). Cadazolid, an experimental drug, has been utilized and compared in several studies with varying results. Methods:: A systematic literature search was performed using electronic databases [Medline, Google Scholar and Cochrane] for eligible studies. Randomized Controlled Trials (RCTs) comparing cadazolid with vancomycin for CDI treatment were included. Demographic variables and outcomes (CDI resolution, CDI recurrence, and adverse events) were collected. The primary outcome was clinical cure rate defined as the resolution of CDI at the end of a 10-day course. Results:: Two studies with three RCTs met the inclusion criteria with a total of 1283 patients with CDI who received either cadazolid 250 mg twice daily (624 patients) or vancomycin 125 mg four times daily (659 patients). Clinical cure rate at the end of the treatment was not statistically significant (pooled OR= 0.82; 95% CI = 0.61 to 1.11; p=0.20; I2= 0%). Sustained clinical response at clinical follow-up was also not significantly different (pooled OR = 1.14; 95% CI = 0.91 to 1.43; p=0.27; I2 = 0 %). Cadazolid had a lower recurrence rate than vancomycin (pooled OR = 0.71; 95% CI = 0.52 to 0.98; p=0.04; I2 = 13 %). Conclusion:: Cadazolid is non-inferior to vancomycin and offers a promising alternative for the treatment of CDI. More studies including RCTs and longitudinal studies with large and diverse patient population are needed to further confirm this. Furthermore, cadazolid should also be compared with fidaxomicin in a head-to-head trial to evaluate their efficacy for CDI.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S599-S599
Author(s):  
Curtis Donskey ◽  
Michelle Hecker ◽  
Christian Rosero

Abstract Background Background: Fecal microbiota transplantation (FMT) is effective for treatment of recurrent Clostridioides difficile infection (CDI). However, limited data are available on the durability of FMT, especially after FMT via capsules and with more than 1 year of follow-up. Figure. Outcomes after FMT in 162 patients with recurrent CDI Methods Methods: A retrospective cohort study was conducted for all patients undergoing FMT from April 2013–November 2020 in a tertiary care hospital. Initial management was considered successful if 1 to 3 FMTs resulted in improved symptoms with no diagnosis of recurrent CDI at 3 months after the initial FMT. Medical record review and telephone interviews were conducted to determine the frequency of recurrent CDI after initial successful management. Results Results: One-hundred sixty-two patients received 228 FMT procedures (range, 1 to 5), including 78 (34%) via colonoscopy, 144 (63%) via freeze-dried oral capsules, and 6 (3%) via nasogastric/duodenal/PEG tube. The median follow-up time after initial FMT was 61 months (range, 10 to 99 months). Initial management was successful in 132 (81%) patients after 1 FMT and in 24 (14%) patients with 1-2 additional FMTs (Figure). During long-term follow-up, 29 recurrences occurred in 22 of 159 (14%) patients evaluated. Ten (34%) of the recurrences occurred greater than 12 months after the initial FMT. Of the 22 patients with recurrence after 3 months, 16 (73%) were successfully managed with CDI therapy or additional FMT. Conclusion Conclusion: In our center, FMT via colonoscopy or freeze-dried capsules was very successful in initial management of recurrent CDI and 85% had a durable response with no further recurrences. However, more than 1 FMT procedure was often required to achieve initial success and to manage late recurrences. Disclosures All Authors: No reported disclosures


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S449-S449
Author(s):  
Emma C Phillips ◽  
Cirle A Warren ◽  
Gregory Madden

Abstract Background Clostridioides difficile infection remains a highly morbid or lethal condition in an unacceptably large proportion of patients. To date, there are limited and conflicting data to support the use of tigecycline for C. difficile infection and the optimal stratification approach, timing (i.e., initial vs. salvage therapy), and duration are unclear. Methods We describe in detail a retrospective cohort of 28 C. difficile inpatients treated with tigecycline at UVA Medical Center. We stratify each patient by the Infectious Diseases Society of America’s guidelines on severity of infection and detail the timing and duration of tigecycline therapy in each case. We further characterize the effect of tigecycline on 90-day mortality and recurrence. Results 9/28 (32.1%) patients were treated with tigecycline for fulminant (presence of hypotension, shock, ileus, or megacolon), and 12/28 (42.9%) for severe (white blood cell count over 15x109/L or creatinine over 1.5mg/dL) C. difficile infection. Tigecycline was used in all cases in combination with oral vancomycin +/- metronidazole. The average duration of therapy was 7.6 days, with tigecycline as initial therapy (use within the first 72 hours of the start of directed antimicrobial therapy) in 7/28 (25%) cases. 90-day mortality occurred in 10/26 (35.7%) patients (two did not reach 90-day follow-up), all 10 of which were in-hospital mortalities and 5/10 (50%) occurred in patients with fulminant infection. 7 of the 16 (43.8%) surviving patients that reached 90-day follow-up had recurrent C. difficile infection. Conclusion Patients selected for treatment with tigecycline for C. difficile infection suffered a high rate of in-hospital mortality, especially among the significant proportion with fulminant disease. The rate of recurrent infection was substantial, contrary to some reports of reduced recurrence with tigecycline from the literature. The outcomes of tigecycline (as adjunct or monotherapy) for treatment of severe/fulminant and refractory infection versus standard treatments warrant further retrospective analysis and the benefit of tigecycline in these settings remains to be proven in well-controlled clinical trials. Disclosures All Authors: No reported disclosures


Swiss Surgery ◽  
2001 ◽  
Vol 7 (1) ◽  
pp. 20-24 ◽  
Author(s):  
Robert ◽  
Mariéthoz ◽  
Pache ◽  
Bertin ◽  
Caulfield ◽  
...  

Objective: Approximately one out of five patients with Graves' disease (GD) undergoes a thyroidectomy after a mean period of 18 months of medical treatment. This retrospective and non-randomized study from a teaching hospital compares short- and long-term results of total (TT) and subtotal thyroidectomies (ST) for this disease. Methods: From 1987 to 1997, 94 patients were operated for GD. Thirty-three patients underwent a TT (mostly since 1993) and 61 a ST (keeping 4 to 8 grams of thyroid tissue - mean 6 g). All patients had received propylthiouracil and/or neo-mercazole and were in a euthyroid state at the time of surgery; they also took potassium iodide (lugol) for ten days before surgery. Results: There were no deaths. Transient hypocalcemia (< 3 months) occurred in 32 patients (15 TT and 17 ST) and persistent hypocalcemia in 8 having had TT. Two patients developed transient recurrent laryngeal nerve palsy after ST (< 3 months). After a median follow-up period of seven years (1-15) with five patients lost to follow-up, 41 patients having had a ST are in a hypothyroid state (73%), thirteen are euthyroid (23%), and two suffered recurrent hyperthyroidism, requiring completion of thyroidectomy. All 33 patients having had TT - with follow-ups averaging two years (0.5-8) - are receiving thyroxin substitution. Conclusions: There were no instances of persistent recurrent laryngeal nerve palsy in either group, but persistent hypoparathyroidism occurred more frequently after TT. Long after ST, hypothyroidism developed in nearly three of four cases, whereas euthyroidy was maintained in only one-fourth; recurrent hyperthyroidy was rare.


2020 ◽  
Vol 33 (6) ◽  
pp. 727-733
Author(s):  
Jasmine A. T. DiCesare ◽  
Alexander M. Tucker ◽  
Irene Say ◽  
Kunal Patel ◽  
Todd H. Lanman ◽  
...  

Cervical spondylosis is one of the most commonly treated conditions in neurosurgery. Increasingly, cervical disc replacement (CDR) has become an alternative to traditional arthrodesis, particularly when treating younger patients. Thus, surgeons continue to gain a greater understanding of short- and long-term complications of arthroplasty. Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental kyphosis at the level of the implant. All implants were locked in the flexion position, and all patients required reoperation. This is the first reported case series of symptomatic segmental kyphosis after CDR.


2019 ◽  
Vol 24 (5) ◽  
pp. 549-557
Author(s):  
Malia McAvoy ◽  
Heather J. McCrea ◽  
Vamsidhar Chavakula ◽  
Hoon Choi ◽  
Wenya Linda Bi ◽  
...  

OBJECTIVEFew studies describe long-term functional outcomes of pediatric patients who have undergone lumbar microdiscectomy (LMD) because of the rarity of pediatric disc herniation and the short follow-up periods. The authors analyzed risk factors, clinical presentation, complications, and functional outcomes of a single-institution series of LMD patients over a 19-year period.METHODSA retrospective case series was conducted of pediatric LMD patients at a large pediatric academic hospital from 1998 to 2017. The authors examined premorbid risk factors, clinical presentation, physical examination findings, type and duration of conservative management, indications for surgical intervention, complications, and postoperative outcomes.RESULTSOver the 19-year study period, 199 patients underwent LMD at the authors’ institution. The mean age at presentation was 16.0 years (range 12–18 years), and 55.8% were female. Of these patients, 70.9% participated in competitive sports, and among those who did not play sports, 65.0% had a body mass index greater than 25 kg/m2. Prior to surgery, conservative management had failed in 98.0% of the patients. Only 3 patients (1.5%) presented with cauda equina syndrome requiring emergent microdiscectomy. Complications included 4 cases of postoperative CSF leak (2.0%), 1 case of a noted intraoperative CSF leak, and 3 cases of wound infection (1.5%). At the first postoperative follow-up appointment, minimal or no pain was reported by 93.3% of patients. The mean time to return to sports was 9.8 weeks. During a mean follow-up duration of 8.2 years, 72.9% of patients did not present again after routine postoperative appointments. The total risk of reoperation was a rate of 7.5% (3.5% of patients underwent reoperation for the same level; 4.5% underwent adjacent-level decompression, and one patient [0.5%] ultimately underwent a fusion).CONCLUSIONSMicrodiscectomy is a safe and effective treatment for long-term relief of pain and return to daily activities among pediatric patients with symptomatic lumbar disc disease in whom conservative management has failed.


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