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Clinical trials in ibd

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https://www.readbyqxmd.com/read/29147137/preventing-disability-in-inflammatory-bowel-disease
#1
REVIEW
Patrick B Allen, Corinne Gower-Rousseau, Silvio Danese, Laurent Peyrin-Biroulet
Disability is a common worldwide health challenge and it has been increasing over the past 3 decades. The treatment paradigm has changed dramatically in inflammatory bowel diseases (IBDs) from control of symptoms towards full control of disease (clinical and endoscopic remission) with the goal of preventing organ damage and disability. These aims are broadly similar to rheumatoid arthritis and multiple sclerosis. Since the 1990s, our attention has focused on quality of life in IBD, which is a subjective measure...
November 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29131034/clinical-trial-and-registry-data
#2
Melinda Gooderham, Kim Papp
Physicians rely on safety and efficacy data from pivotal trials to guide treatment decisions and manage patients. Even with robust clinical trial data, there remain questions regarding rare safety events and generalizability. Registries complement clinical trials. By evaluating effectiveness and safety in broad patient populations and often providing longer term or larger numbers of patients or both compared to clinical trials, registries consolidate and may extend the safety observations derived from pivotal trials...
2018: Current Problems in Dermatology
https://www.readbyqxmd.com/read/29130220/-current-research-progress-and-thinking-of-fecal-microbiota-transplantation-for-the-treatment-of-gastrointestinal-disorders
#3
Ning Li, Hongliang Tian
Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI...
October 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/29127772/interventions-for-treating-collagenous-colitis
#4
REVIEW
Tahir S Kafil, Tran M Nguyen, Petrease H Patton, John K MacDonald, Nilesh Chande, John Wd McDonald
BACKGROUND: Collagenous colitis is a cause of chronic diarrhea. This updated review was performed to identify therapies for collagenous colitis that have been assessed in randomized controlled trials (RCTs). OBJECTIVES: The primary objective was to assess the benefits and harms of treatments for collagenous colitis. SEARCH METHODS: We searched CENTRAL, the Cochrane IBD Group Specialized Register, MEDLINE and EMBASE from inception to 7 November 2016...
November 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29124994/a-review-on-biosimilar-infliximab-ct-p13-in-the-treatment-of-inflammatory-bowel-disease
#5
Klaudia Farkas, Tamás Molnár
The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD...
November 10, 2017: Immunotherapy
https://www.readbyqxmd.com/read/29120908/patients-beliefs-about-medicine-are-associated-with-early-thiopurine-discontinuation-in-patients-with-inflammatory-bowel-diseases
#6
Mark M T J Broekman, Marieke J H Coenen, Geert J Wanten, Corine J van Marrewijk, Wietske Kievit, Olaf H Klungel, André L M Verbeek, Dennis R Wong, Piet M Hooymans, Henk-Jan Guchelaar, Hans Scheffer, Luc J J Derijks, Marcel L Bouvy, Dirk J de Jong
BACKGROUND: Patients' beliefs about medicine may either reflect the necessity for treatment or concerns regarding the treatment. We explored the extent to which these beliefs have an effect on thiopurine metabolite levels and premature discontinuation in patients with inflammatory bowel disease (IBD). PATIENTS AND METHODS: Patients enrolled in the 'Thiopurine response Optimization by Pharmacogenetic testing in Inflammatory Bowel Disease Clinics' (TOPIC) trial were asked to complete the Beliefs about Medicine Questionnaire (BMQ) 4 weeks after thiopurine initiation...
November 8, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29104284/jak-inhibition-as-a-therapeutic-strategy-for-immune-and-inflammatory-diseases
#7
REVIEW
Daniella M Schwartz, Yuka Kanno, Alejandro Villarino, Michael Ward, Massimo Gadina, John J O'Shea
The discovery of cytokines as key drivers of immune-mediated diseases has spurred efforts to target their associated signalling pathways. Janus kinases (JAKs) are essential signalling mediators downstream of many pro-inflammatory cytokines, and small-molecule inhibitors of JAKs (jakinibs) have gained traction as safe and efficacious options for the treatment of inflammation-driven pathologies such as rheumatoid arthritis, psoriasis and inflammatory bowel disease. Building on the clinical success of first-generation jakinibs, second-generation compounds that claim to be more selective are currently undergoing development and proceeding to clinical trials...
November 6, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29084080/metronidazole-or-rifaximin-for-treatment-of-clostridium-difficile-in-pediatric-patients-with-inflammatory-bowel-disease-a-randomized-clinical-trial
#8
Agnieszka Gawronska, Marcin Banasiuk, Dominika Lachowicz, Hanna Pituch, Piotr Albrecht, Aleksandra Banaszkiewicz
BACKGROUND: Interestingly, Clostridium difficile infection (CDI) worsens the course of inflammatory bowel disease (IBD); however, there is a paucity of data regarding the treatment of CDI in this group of patients. METHODS: This was a prospective, single-blind trial. Children with flare of IBD and CDI were randomly assigned to receive metronidazole or rifaximin orally for 14 days. CDI was diagnosed based on a positive well-type enzyme immunoassay (EIA) toxins A/B stool test for C...
December 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29075900/clinical-importance-of-il-22-cascade-in-ibd
#9
REVIEW
Atsushi Mizoguchi, Arisa Yano, Hidetomo Himuro, Yui Ezaki, Takayuki Sadanaga, Emiko Mizoguchi
IL-22 is a relatively new cytokine that is characterized by several unique biological properties. In the intestines, the effect of IL-22 is restricted mainly to non-lymphoid cells such as epithelial cells. Interestingly, the expression pattern and major cellular source of IL-22 have distinct difference between large and small intestines. IL-22 possesses an ability to constitutively activate STAT3 for promoting epithelial cell regeneration and reinforcing mucosal barrier integrity through stimulating the expression of anti-bacterial peptide and mucins...
October 26, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/29074448/patient-reported-outcome-measures-for-use-in-clinical-trials-and-clinical-practice-in-inflammatory-bowel-diseases-a-systematic-review
#10
REVIEW
M J de Jong, R Huibregtse, A A M Masclee, D M A E Jonkers, M J Pierik
BACKGROUND & AIMS: Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. METHODS: A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles...
October 23, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29064884/efficacy-of-preoperative-oral-antibiotic-prophylaxis-for-the-prevention-of-surgical-site-infections-in-patients-with-crohn-disease-a-randomized-controlled-trial
#11
Motoi Uchino, Hiroki Ikeuchi, Toshihiro Bando, Teruhiro Chohno, Hirofumi Sasaki, Yuki Horio, Kazuhiko Nakajima, Yoshio Takesue
OBJECTIVES: We investigated the efficacy of oral antimicrobial prophylaxis in patients undergoing surgery for Crohn disease. BACKGROUND: Although oral antibiotic prophylaxis with mechanical bowel preparation has been recommended for colorectal surgery, the use of this approach remains somewhat controversial. Moreover, the efficacy of this approach for inflammatory bowel disease also remains unclear. METHODS: This study was conducted as a randomized controlled trial at the Hyogo College of Medicine...
October 23, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/29057539/comparative-safety-of-systemic-and-low-bioavailability-steroids-in-inflammatory-bowel-disease-systematic-review-and-network-meta-analysis
#12
Stefanos Bonovas, Georgios K Nikolopoulos, Theodore Lytras, Gionata Fiorino, Laurent Peyrin-Biroulet, Silvio Danese
AIMS: Oral systemic corticosteroids have been used to induce remission in patients with active inflammatory bowel disease (IBD) for over 50 years; however, the wide array of adverse events (AEs) associated with these drugs prompted the development of steroid compounds with targeted delivery and low systemic bioavailability. This study assessed corticosteroids' comparative harm using network meta-analysis. METHODS: We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory authorities' websites and major conference proceedings, through March 2017...
October 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29051788/emerging-oral-targeted-therapies-in-inflammatory-bowel-diseases-opportunities-and-challenges
#13
REVIEW
Marcel Vetter, Markus F Neurath
To improve quality of life and prevent long-term risks in patients with inflammatory bowel diseases (IBDs: Crohn's disease, ulcerative colitis), it is essential to suppress inflammatory activity adequately. However, corticosteroids are only suitable for therapy of acute flares and the evidence for positive effects of immunosuppressive substances like azathioprine or 6-mercapropurine is mainly limited to maintenance of remission. In addition, only subgroups of patients benefit from biologicals targeting tumour necrosis factor α or α4β7 integrins...
October 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29046094/ostomy-creation-with-fewer-sutures-using-tissue-adhesives-cyanoacrylates-in-inflammatory-bowel-disease-a-pilot-study
#14
M Uchino, H Ikeuchi, T Bando, H Sasaki, T Chohno, Y Horio, Y Takesue
Introduction Fistula formation around the ostomy site is a stoma-related complication often requiring surgical intervention. This complication may be caused by sutures or may develop as a complication of inflammatory bowel disease. Before conducting a clinical trial, we set out to investigate the safety of ostomy creation with fewer sutures using tissue adhesives in this pilot study. Methods Patients with inflammatory bowel disease who required surgery with ostomy creation at the Hyogo College of Medicine between January 2014 and December 2015 were enrolled...
October 19, 2017: Annals of the Royal College of Surgeons of England
https://www.readbyqxmd.com/read/29032748/mechanistic-understanding-of-herbal-therapy-in-inflammatory-bowel-disease
#15
Luqing Zhao, Shengsheng Zhang, Peijian He
The incidence and prevalence of inflammatory bowel diseases (IBD), which comprise ulcerative colitis and Crohn's disease, are increasing dramatically worldwide. Immunomodulators and biological agents can help but cause severe side effects in long-term use. As such, complementary and alternative medicine, in particular herbal remedy, is becoming more and more popular in the treatment of IBD patients. Many natural compounds have been used in clinical trials and some have been proven promising in IBD treatment...
October 10, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29028958/development-of-clinical-prediction-models-for-surgery-and-complications-in-crohn-s-disease
#16
Leonardo Guizzetti, Guangyong Zou, Reena Khanna, Parambir S Dulai, William J Sandborn, Vipul Jairath, Brian G Feagan
Background and Aims: Crohn's disease-related complications account for a substantial proportion of inflammatory bowel disease-associated healthcare expenditure. Identifying patients at risk for complications may allow for targeted use of early therapeutic interventions to off-set this natural course. We aimed to develop risk prediction models for Crohn's disease-related surgery and complications. Methods: Using data from the Randomized Evaluation of an Algorithm for Crohn's Disease cluster-randomized clinical Trial (REACT), which involved 1898 patients from 40 community practices...
September 19, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29023853/antibiotics-gut-microbiome-and-obesity
#17
Karen S W Leong, José G B Derraik, Paul L Hofman, Wayne S Cutfield
Antibiotics have been hailed by many as 'miracle drugs' that have been effectively treating infectious diseases for over a century, leading to a marked reduction in morbidity and mortality. However, with the increasing use of antibiotics, we are now faced not only with the increasing threat of antibiotic resistance, but also with a rising concern about potential long-term effects of antibiotics on human health, including the development of obesity. The obesity pandemic continues to increase, a problem that affects both adults and children alike...
October 12, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/29019856/cost-utility-analysis-thiopurines-plus-endoscopy-guided-biological-step-up-therapy-is-the-optimal-management-of-postoperative-crohn-s-disease
#18
Roberto Candia, David Naimark, Beate Sander, Geoffrey C Nguyen
BACKGROUND: Postoperative recurrence of Crohn's disease is common. This study sought to assess whether the postoperative management should be based on biological therapy alone or combined with thiopurines and whether the therapy should be started immediately after surgery or guided by either endoscopic or clinical recurrence. METHODS: A Markov model was developed to estimate expected health outcomes in quality-adjusted life years (QALYs) and costs in Canadian dollars (CAD$) accrued by hypothetical patients with high recurrence risk after ileocolic resection...
November 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29019427/management-of-inflammatory-bowel-disease-related-anemia-and-iron-deficiency-with-specific-reference-to-the-role-of-intravenous-iron-in-current-practice
#19
Jürgen Stein, Ayşegül Aksan, Karima Farrag, Axel Dignass, Heinfried H Radeke
Anemia is a common extraintestinal manifestation in patients with inflammatory bowel disease, impacting disease prognosis, morbidity, hospitalization rates and time lost from work. While iron deficiency anemia and anemia of chronic inflammation predominate, combinations of hematimetric and biochemical markers facilitate the diagnosis and targeted therapy of other etiologies according to their underlying pathophysiological causes. Intravenous iron replacement is currently recommended in IBD patients with moderate to severe anemia or intolerance to oral iron...
November 5, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29016235/telemedicine-support-groups-for-home-parenteral-nutrition-users
#20
Eve-Lynn Nelson, Donna Macan Yadrich, Noreen Thompson, Shawna Wright, Kathaleen Stone, Natasia Adams, Marilyn Werkowitch, Carol E Smith
Patients receiving home parenteral nutrition (HPN), a life-sustaining intravenous (IV) infusion that provides nourishment and hydration to patients with short gut or inflammatory bowel diseases, are often isolated and not in visual contact with peers or health providers. One completed clinical trial (Clinical Trials.gov NCT0190028) and 1 ongoing clinical trial (Clinical Trials.gov NCT02987569) are evaluating a mobile videoconferencing-delivered support group intervention for patients on HPN and their caregivers...
December 2017: Nutrition in Clinical Practice
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