Updates in Clinical, Endoscopic, and Histologic Composite and Co-primary Endpoints for Clinical Trials in Inflammatory Bowel Disease

2021 ◽  
Author(s):  
Chung Sang Tse ◽  
Vipul Jairath ◽  
Brian G. Feagan ◽  
William J. Sandborn
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Primary Endpoints ◽  
Inflammatory Bowel

Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Effects ◽  
Bowel Disease ◽  
Relapse Prevention ◽  
Remission Induction ◽  
Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

scholarly journals P051 Use of digital technology to boost patient recruitment in inflammatory bowel disease clinical trials

2017 ◽  
Vol 11 (suppl_1) ◽  
pp. S103-S104
Author(s):  
Y. Bouhnik ◽  
A. Amiot ◽  
A. Nuzzo ◽  
A. Attar ◽  
P.K. Kondamudi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Digital Technology ◽  
Patient Recruitment ◽  
Inflammatory Bowel

scholarly journals Preferences of Adult Patients With Inflammatory Bowel Disease for Attributes of Clinical Trials: Evidence From a Choice-Based Conjoint Analysis

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Dallas Wood ◽  
Katherine Kosa ◽  
Derek Brown ◽  
Orna G Ehrlich ◽  
Peter D R Higgins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Latent Class ◽  
Open Label ◽  
Monetary Compensation ◽  
Open Label Extension ◽  
Inflammatory Bowel ◽  
New Treatments

Abstract Background Clinical trial recruitment is the rate-limiting step in developing new treatments. To understand inflammatory bowel disease (IBD) patient recruitment, we investigated two questions: Do changes in clinical trial attributes, like monetary compensation, influence recruitment rates, and does this influence differ across subgroups? Methods We answered these questions through a conjoint survey of 949 adult IBD patients. Results Recruitment rates are influenced by trial attributes: small but significant increases are predicted with lower placebo rates, reduced number of endoscopies, less time commitment, open label extension, and increased involvement of participant’s primary GI physician. A much stronger effect was found with increased monetary compensation. Latent class analysis indicated three patient subgroups: some patients quite willing to participate in IBD trials, some quite reluctant, and others who can be persuaded. The persuadable group is quite sensitive to monetary compensation, and payments up to US$2,000 for a 1-year study could significantly increase recruitment rates for IBD clinical trials. Conclusions This innovative study provides researchers with a framework for predicting recruitment rates for different IBD clinical trials.

scholarly journals Clinical Trials for Inflammatory Bowel Disease: Global Guidance During the COVID-19 Pandemic

2020 ◽  
Vol 14 (Supplement_3) ◽  
pp. S820-S820 ◽  
Author(s):  
Walter Reinisch ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet ◽  
Edward V Loftus
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Global Guidance ◽  
Inflammatory Bowel

Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease

BioDrugs ◽  
2020 ◽  
Vol 34 (6) ◽  
pp. 713-721 ◽  
Author(s):  
Ahmed Almradi ◽  
Jurij Hanzel ◽  
Rocio Sedano ◽  
Claire E. Parker ◽  
Brian G. Feagan ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Inflammatory Bowel
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