scholarly journals Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

2021 ◽  
Vol 9 (3) ◽  
pp. 548
Author(s):  
R. E. Ooijevaar ◽  
E. van Nood ◽  
A. Goorhuis ◽  
E. M. Terveer ◽  
J. van Prehn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Randomized Controlled ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

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.

scholarly journals Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse

2021 ◽  
Author(s):  
Nadim Bikhazi ◽  
Randall A. Ow ◽  
Ellen M. O'Malley ◽  
Nora Perkins ◽  
Douglas M. Sidle ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Nasal Valve ◽  
Time Points ◽  
Randomized Controlled ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractWe report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.

scholarly journals 1016. Long-term Follow-up after Fecal Microbiota Transplantation via Colonoscopy or Freeze-Dried Capsules for Recurrent Clostridioides difficile infection

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S599-S599
Author(s):  
Curtis Donskey ◽  
Michelle Hecker ◽  
Christian Rosero
Keyword(s):  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Care Hospital ◽  
Initial Management ◽  
Clostridioides Difficile ◽  
Freeze Dried ◽  
Long Term Follow Up ◽  
Clostridioides Difficile Infection

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

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Long-Term Effects of Resistance Exercise Training on Cognition and Brain Volume in Older Women: Results from a Randomized Controlled Trial

2015 ◽  
Vol 21 (10) ◽  
pp. 745-756 ◽  
Author(s):  
John R. Best ◽  
Bryan K. Chiu ◽  
Chun Liang Hsu ◽  
Lindsay S. Nagamatsu ◽  
Teresa Liu-Ambrose
Keyword(s):  
Randomized Controlled Trial ◽  
White Matter ◽  
Resistance Training ◽  
Exercise Training ◽  
Older Women ◽  
Controlled Trial ◽  
Resistance Exercise Training ◽  
Randomized Controlled

AbstractAerobic exercise training has been shown to attenuate cognitive decline and reduce brain atrophy with advancing age. The extent to which resistance exercise training improves cognition and prevents brain atrophy is less known, and few studies include long-term follow-up cognitive and neuroimaging assessments. We report data from a randomized controlled trial of 155 older women, who engaged in 52 weeks of resistance training (either once- or twice-weekly) or balance-and-toning (twice-weekly). Executive functioning and memory were assessed at baseline, 1-year follow-up (i.e., immediately post-intervention), and 2-year follow-up. A subset underwent structural magnetic resonance imaging scans at those time points. At 2-year follow-up, both frequencies of resistance training promoted executive function compared to balance-and-toning (standardized difference [d]=.31–.48). Additionally, twice-weekly resistance training promoted memory (d=.45), reduced cortical white matter atrophy (d=.45), and increased peak muscle power (d=.27) at 2-year follow-up relative to balance-and-toning. These effects were independent of one another. These findings suggest resistance training may have a long-term impact on cognition and white matter volume in older women. (JINS, 2015,21, 745–756)

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