Lack of Association with Patient Demographics and Outcomes in Punch CD 2, a Randomized Controlled Trial of RBX2660, a Microbiota-Based Drug for Recurrent Clostridium Difficile Infection

2017 ◽  
Vol 152 (5) ◽  
pp. S951-S952
Author(s):  
Gail A. Hecht ◽  
Robert Orenstein ◽  
Erik R. Dubberke ◽  
Christine Lee ◽  
Sahil Khanna
Keyword(s):  
Randomized Controlled Trial ◽  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Controlled Trial ◽  
Patient Demographics ◽  
Randomized Controlled ◽  
Recurrent Clostridium Difficile Infection

scholarly journals A randomized controlled trial of probiotics for Clostridium difficile infection in adults (PICO)

2017 ◽  
Vol 72 (11) ◽  
pp. 3177-3180 ◽  
Author(s):  
Anna K Barker ◽  
Megan Duster ◽  
Susan Valentine ◽  
Timothy Hess ◽  
Laurie Archbald-Pannone ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Comparison of colon adenoma detection rates using cap-assisted and Endocuff-assisted colonoscopy: a randomized controlled trial

2019 ◽  
Vol 07 (12) ◽  
pp. E1585-E1591 ◽  
Author(s):  
Joseph Marsano ◽  
Sheeva Johnson ◽  
Stephanie Yan ◽  
Latifat Alli-Akintade ◽  
Machelle Wilson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyp Size ◽  
Withdrawal Time ◽  
Detection Rates ◽  
Patient Demographics ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Significant Difference ◽  
Adenoma Detection Rates

Abstract Objectives and study aim Colonoscopy prevents colorectal cancer by removing adenomatous polyps, but missed adenomas lead to interval cancers. Different devices have been used to increase adenoma detection rates (ADR). Two such devices of interest are the transparent cap (Olympus) and Endocuff (ARC Medical). Our study aimed to compare differences in ADR between Endocuff-assisted colonoscopy (EAC), cap-assisted colonoscopy (CAC) and standard colonoscopy (SC). Patients and methods A sample size of 126 subjects was calculated to determine an effect size of 30 %. Patients undergoing screening or surveillance colonoscopy between March 2016 and January 2017 were randomized to SC, CAC or EAC groups. Three experienced endoscopists performed all colonoscopies. Patient demographics, procedure indication, Boston Bowel Prep Score (BBPS), withdrawal time, polyp size, location, histopathology, were analyzed. Results There was no difference in ADR (52 %, 40 % and 54 %) in the SC, CAC and EAC groups respectively (P = 0.4). Similar findings were also observed for proximal ADR (45 %, 35 %, and 50 %, P = 0.4) and SSA detection rate (16 %, 14 %, and 23 %, P = 0.5). EAC detected higher mean ADR per colonoscopy compared to CAC (1.70 vs 0.76, P = 0.01). However, there was no significant difference in mean ADR per positive colonoscopy (2.08, 1.63, and 2.59, P = 0.21). Conclusion In a randomized controlled trial comparing AC to CAC and SC, neither device conferred additional benefits in ADR among high detectors. When comparing each device, EAC may be better than CAC at detecting more total adenomas.

scholarly journals Is a Single Fecal Microbiota Transplant a Promising Treatment for Recurrent Clostridium difficile Infection?

2018 ◽  
Vol 5 (3) ◽  
Author(s):  
Susy S Hota ◽  
Susan M Poutanen
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Fecal Microbiota Transplantation ◽  
Clinical Effectiveness ◽  
Fecal Microbiota ◽  
Controlled Trials ◽  
Fecal Microbiota Transplant ◽  
Randomized Controlled ◽  
Recurrent Clostridium Difficile Infection ◽  
Promising Treatment

Abstract Clostridium difficile infection, a common hospital-associated infection, is a gastrointestinal illness that becomes recurrent in about 25% of infected patients. Fecal microbiota transplantation (FMT) is increasingly supported by clinical trials as an effective treatment for recurrent Clostridium difficile infection, but a number of questions remain about how it can be optimally performed. In this Perspective, we discuss controversies in FMT methodologies and reporting within randomized controlled trials, all of which may influence clinical outcomes in treated patients. Finally, we focus on the question of whether single vs multiple FMTs are necessary to achieve favorable outcomes for the treatment of recurrent Clostridium difficile infection, postulating on why there may be an association between number of FMTs and clinical effectiveness.

scholarly journals Oral Vancomycin Followed by Fecal Transplantation Versus Tapering Oral Vancomycin Treatment for Recurrent Clostridium difficile Infection: An Open-Label, Randomized Controlled Trial

2016 ◽  
Vol 64 (3) ◽  
pp. 265-271 ◽  
Author(s):  
Susy S Hota ◽  
Valerie Sales ◽  
George Tomlinson ◽  
Mary Jane Salpeter ◽  
Allison McGeer ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Oral Vancomycin ◽  
Open Label ◽  
Fecal Transplantation ◽  
Recurrent Clostridium Difficile Infection ◽  
Microbiota Analysis ◽  
Vancomycin Treatment

Abstract Background Fecal transplantation (FT) is a promising treatment for recurrent Clostridium difficile infection (CDI), but its true effectiveness remains unknown. We compared 14 days of oral vancomycin followed by a single FT by enema with oral vancomycin taper (standard of care) in adult patients experiencing acute recurrence of CDI. Methods In a phase 2/3, single-center, open-label trial, participants from Ontario, Canada, experiencing recurrence of CDI were randomly assigned in a 1:1 ratio to 14 days of oral vancomycin treatment followed by a single 500-mL FT by enema, or a 6-week taper of oral vancomycin. Patients with significant immunocompromise, history of fulminant CDI, or irreversible bleeding disorders were excluded. The primary endpoint was CDI recurrence within 120 days. Microbiota analysis was performed on fecal filtrate from donors and stool samples from FT recipients, as available. Results The study was terminated at the interim analysis after randomizing 30 patients. Nine of 16 (56.2%) patients who received FT and 5 of 12 (41.7%) in the vancomycin taper group experienced recurrence of CDI, corresponding with symptom resolution in 43.8% and 58.3%, respectively. Fecal microbiota analysis of 3 successful FT recipients demonstrated increased diversity. A futility analysis did not support continuing the study. Adverse events were similar in both groups and uncommon. Conclusions In patients experiencing an acute episode of recurrent CDI, a single FT by enema was not significantly different from oral vancomycin taper in reducing recurrent CDI. Further research is needed to explore optimal donor selection, FT preparation, route, timing, and number of administrations. Clinical Trials Registration NCT01226992.

Sign in / Sign up

Export Citation Format

Share Document