INTRALESIONAL INJECTION OF ADALIMUMAB IN INTESTINAL STRICTURES OF PATIENTS WITH CROHN’S DISEASE: A RANDOMIZED, MULTICENTER, PROSPECTIVE CLINICAL TRIAL

2020 ◽  
Author(s):  
B González-Suárez ◽  
A Giordano ◽  
C Romero ◽  
S Khorrami ◽  
A Gutierrez ◽  
...  
2020 ◽  
Vol 91 (6) ◽  
pp. AB277
Author(s):  
Begoña Gonzalez Suarez ◽  
Antonio Giordano ◽  
Cristina Romero Mascarell ◽  
Sam Khorrami ◽  
Ana Gutiérrez ◽  
...  

2018 ◽  
Vol 154 (6) ◽  
pp. S-847 ◽  
Author(s):  
Geert R. D'Haens ◽  
Zeljko Cabrijan ◽  
Michael Eberhardson ◽  
Remco M. van den Berg ◽  
Mark Löwenberg ◽  
...  

2009 ◽  
Vol 45 (1) ◽  
pp. 24-29 ◽  
Author(s):  
Takayuki Yamamoto ◽  
Maki Nakahigashi ◽  
Satoru Umegae ◽  
Koichi Matsumoto

2018 ◽  
Vol 12 (supplement_1) ◽  
pp. S397-S398 ◽  
Author(s):  
G D'Haens ◽  
Z Cabrijan ◽  
M Eberhardson ◽  
R van den Bergh ◽  
M Löwenberg ◽  
...  

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1429
Author(s):  
Theo Wallimann ◽  
Caroline H. T. Hall ◽  
Sean P. Colgan ◽  
Louise E. Glover

Based on theoretical considerations, experimental data with cells in vitro, animal studies in vivo, as well as a single case pilot study with one colitis patient, a consolidated hypothesis can be put forward, stating that “oral supplementation with creatine monohydrate (Cr), a pleiotropic cellular energy precursor, is likely to be effective in inducing a favorable response and/or remission in patients with inflammatory bowel diseases (IBD), like ulcerative colitis and/or Crohn’s disease”. A current pilot clinical trial that incorporates the use of oral Cr at a dose of 2 × 7 g per day, over an initial period of 2 months in conjunction with ongoing therapies (NCT02463305) will be informative for the proposed larger, more long-term Cr supplementation study of 2 × 3–5 g of Cr per day for a time of 3–6 months. This strategy should be insightful to the potential for Cr in reducing or alleviating the symptoms of IBD. Supplementation with chemically pure Cr, a natural nutritional supplement, is well tolerated not only by healthy subjects, but also by patients with diverse neuromuscular diseases. If the outcome of such a clinical pilot study with Cr as monotherapy or in conjunction with metformin were positive, oral Cr supplementation could then be used in the future as potentially useful adjuvant therapeutic intervention for patients with IBD, preferably together with standard medication used for treating patients with chronic ulcerative colitis and/or Crohn’s disease.


2016 ◽  
Vol 150 (4) ◽  
pp. S182 ◽  
Author(s):  
Takayuki Matsumoto ◽  
Satoshi Motoya ◽  
Kenji Watanabe ◽  
Tadakazu Hisamatsu ◽  
Hiroshi Nakase ◽  
...  

Author(s):  
Jurij Hanzel ◽  
Vipul Jairath ◽  
Peter De Cruz ◽  
Leonardo Guizzetti ◽  
Lisa M Shackelton ◽  
...  

Abstract Background The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn’s disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity. Methods An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds. Results Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain. Conclusions A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.


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