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Gastroenterology RCT

Rachel Rosen, Yvan Vandenplas, Maartje Singendonk, Michael Cabana, Carlo DiLorenzo, Frederic Gottrand, Sandeep Gupta, Miranda Langendam, Annamaria Staiano, Nikhil Thapar, Neelesh Tipnis, Merit Tabbers
This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated...
March 2018: Journal of Pediatric Gastroenterology and Nutrition
Rachel Rosen, Yvan Vandenplas, Maartje Singendonk, Michael Cabana, Carlo Di Lorenzo, Frederic Gottrand, Sandeep Gupta, Miranda Langendam, Annamaria Staiano, Nikhil Thapar, Neelesh Tipnis, Merit Tabbers
This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated...
January 25, 2018: Journal of Pediatric Gastroenterology and Nutrition
Mariyana Schoultz, Leah Macaden, Gill Hubbard
BACKGROUND: Mindfulness-based interventions have shown to improve depression and anxiety symptoms as well as quality of life in patients with inflammatory bowel disease (IBD). However, little is known about the experiences of this group of patients participating in mindfulness interventions. This paper sets out to explore the perspectives of patients with IBD recruited to a pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) about the intervention. METHODS: In a qualitative study nested within a parallel two-arm pilot RCT of mindfulness-based cognitive therapy for patients with IBD, two focus group interviews (using the same schedule) and a free text postal survey were conducted...
2016: Pilot and Feasibility Studies
Y A McKenzie, J Thompson, P Gulia, M C E Lomer
BACKGROUND: Probiotics are often taken by individuals with irritable bowel syndrome (IBS). Which products are effective is unclear, despite an increasing research base. This project will systematically review which strain- and dose- specific probiotics can be recommended to adults with IBS to improve symptoms and quality of life (QoL). It is part of a broader systematic review to update British Dietetic Association guidelines for the dietary management of IBS in adults. METHODS: CINAHL, Cochrane, Embase, Medline, Scopus and Web of Science were searched for systematic reviews (SRs) of randomised controlled trial (RCT)s recruiting adults with IBS comparing probiotic intervention with placebo...
October 2016: Journal of Human Nutrition and Dietetics: the Official Journal of the British Dietetic Association
M S Volz, B Siegmund, W Häuser
BACKGROUND: The medical use of cannabis is discussed in gastroenterology for inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), and chronic pancreatitis. MATERIALS AND METHODS: A systematic literature search until March 2015 was performed in the databases Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, , and Randomized controlled trials (RCT) investigating herbal cannabis and/or pharmaceutical cannabinoids in IBD, IBS, or chronic pancreatitis with a study duration of ≥ 4 weeks and a sample size of at least n = 10 per study arm were identified...
February 2016: Der Schmerz
Mariyana Schoultz, Iain Atherton, Angus Watson
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients; thus, IBD patients report higher rates of depression and anxiety than the general population. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms. There has been no randomized controlled trial (RCT) testing the use of MBCT in IBD patients...
2015: Trials
Claire Daly, Prashanth Vennalaganti, Samad Soudagar, Ben Hornung, Prateek Sharma, Neil Gupta
BACKGROUND AND AIMS: Previous studies have shown that narrow-band imaging (NBI) can be taught to inexperienced gastroenterologists. However, it is unknown whether in-person training is more effective than self-directed training. The objective of this study was to compare the accuracy of diagnosing Barrett's esophagus (BE)-associated neoplasia by trainees with no prior NBI experience between in-classroom and self-directed didactic training programs. METHODS: This was a randomized controlled trial that took place at 2 tertiary-care medical centers, involving 33 participants--12 second-year medical students, 8 first-year gastroenterology fellows, 7 second-year gastroenterology fellows, and 6 third-year gastroenterology fellows...
January 2016: Gastrointestinal Endoscopy
Yongjun Wang, John K MacDonald, Ben Vandermeer, Anne Marie Griffiths, Wael El-Matary
BACKGROUND: Methotrexate, a folate antagonist, is an immunosuppressant drug that is effective for treating several inflammatory disorders including Crohn's disease. Ulcerative colitis, a related chronic inflammatory bowel disease, can be challenging to treat. T his updated systematic review summarizes the current evidence on the use of methotrexate for induction maintenance of remission in ulcerative colitis. OBJECTIVES: The objectives of this review were to assess the efficacy and safety of methotrexate for maintenance of remission in patients with ulcerative colitis...
2015: Cochrane Database of Systematic Reviews
Lena Böhn, Stine Störsrud, Therese Liljebo, Lena Collin, Perjohan Lindfors, Hans Törnblom, Magnus Simrén
BACKGROUND & AIMS: A diet with reduced content of fermentable short-chain carbohydrates (fermentable oligo-, di-, monosaccharides, and polyols [FODMAPs]) has been reported to be effective in the treatment of patients with irritable bowel syndrome (IBS). However, there is no evidence of its superiority to traditional dietary advice for these patients. We compared the effects of a diet low in FODMAPs with traditional dietary advice in a randomized controlled trial of patients with IBS...
November 2015: Gastroenterology
Nilesh Chande, Yongjun Wang, John Wd McDonald, John K MacDonald
BACKGROUND: There are a limited number of treatment options for patients with ulcerative colitis (UC). An increased risk of thrombosis in UC coupled with an observation that UC patients being treated with anticoagulant therapy for thrombotic events had an improvement in their bowel symptoms led to trials examining the use of unfractionated heparin (UFH) and low molecular weight heparins (LMWH) in patients with active UC. OBJECTIVES: To review randomized trials examining the efficacy of unfractionated heparin (UFH) or low molecular weight heparins (LMWH) for remission induction in patients with ulcerative colitis...
2015: Cochrane Database of Systematic Reviews
Sigrid Elsenbruch, Paul Enck
Placebo effects in clinical trials have sparked an interest in the placebo phenomenon, both in randomized controlled trials (RCTs) and in experimental gastroenterology. RCTs have demonstrated similar short-term and long-term placebo response rates in gastrointestinal compared to other medical diagnoses. Most mediators and moderators of placebo effects in gastrointestinal diseases are also of similar type and size to other medical diagnoses and not specific for gastrointestinal diagnoses. Other characteristics such as an increase in the placebo response over time and the placebo-enhancing effects of unbalanced randomization were not seen, at least in IBS...
August 2015: Nature Reviews. Gastroenterology & Hepatology
Mohsen Masoodi, Mahshid Talebi-Taher, Khadijeh Tabatabaie, Siamak Khaleghi, Amir-Hossein Faghihi, Shahram Agah, Reyhaneh Asadi
BACKGROUND Eradication of Helicobacter pylori infection plays a crucial role in the treatment of peptic ulcer. Clarithromycin resistance is a major cause of treatment failure. This randomized clinical trial aimed at evaluating the efficacy of a clarithromycin versus gemifloxacin containing quadruple therapy regimen in eradication of H.pylori infection. METHODS In this randomized double blind clinical trial (RCT 2012102011054N2), a total of 120 patients were randomized to two groups of 60 patients each. Patients with proven H...
April 2015: Middle East Journal of Digestive Diseases
Keisuke Hata, Junko Kishikawa, Hiroyuki Anzai, Takahide Shinagawa, Shinsuke Kazama, Hiroaki Ishii, Hiroaki Nozawa, Kazushige Kawai, Tomomichi Kiyomatsu, Junichiro Tanaka, Toshiaki Tanaka, Takeshi Nishikawa, Kensuke Otani, Koji Yasuda, Hironori Yamaguchi, Soichiro Ishihara, Eiji Sunami, Joji Kitayama, Toshiaki Watanabe
Long-standing ulcerative colitis patients are known to be at high risk for the development of colorectal cancer. Therefore, surveillance colonoscopy has been recommended for these patients. Because colitis-associated colorectal cancer may be difficult to identify even by colonoscopy, a random biopsy method has been recommended. However, the procedure of carrying out a random biopsy is tedious and its effectiveness has also not yet been demonstrated. Instead, targeted biopsy with chromoendoscopy has gained popularity in European and Asian countries...
April 2016: Digestive Endoscopy: Official Journal of the Japan Gastroenterological Endoscopy Society
Véronique Vitton, Alban Benezech, Stéphane Honoré, Patrick Sudour, Nathalie Lesavre, Pascal Auquier, Karine Baumstarck
BACKGROUND: The prevalence of chronic constipation is about 15 % in Western countries with a significant impact on quality of life and health care costs. The first-line therapy, based on medical treatment combined with laxatives and dietary rules, is often disappointing. Interferential therapy is a new treatment that has demonstrated its efficiency in the treatment of chronic constipation in children and encouraging results in adults. The primary objective of this study is to assess the efficacy of interferential therapy during 8 weeks in adult patients...
May 28, 2015: Trials
F van Stiphout, J E F Zwart-van Rijkom, J E C M Aarts, H Koffijberg, E Klarenbeek-deJonge, M Krulder, K C B Roes, A C G Egberts, E W M T ter Braak
BACKGROUND: Using information technology for medication management is an opportunity to help physicians to improve the quality of their documentation and communication and ultimately to improve patient care and patient safety. Physician education is necessary to take full advantage of information technology systems. In this trial, we seek to determine the effectiveness of an intensive educational intervention compared with the standard approach in improving information technology-mediated medication management and in reducing potential adverse drug events in the outpatient clinic...
2015: Trials
Timothy J Wilt, Russell P Harris, Amir Qaseem
BACKGROUND: Cancer screening is one approach to reducing cancer-related morbidity and mortality rates. Screening strategies vary in intensity. Higher-intensity strategies are not necessarily higher value. High-value strategies provide a degree of benefits that clearly justifies the harms and costs incurred; low-value screening provides limited or no benefits to justify the harms and costs. When cancer screening leads to benefits, an optimal intensity of screening maximizes value. Some aspects of screening practices, especially overuse and underuse, are low value...
May 19, 2015: Annals of Internal Medicine
Noortje G Rossen, John K MacDonald, Elisabeth M de Vries, Geert R D'Haens, Willem M de Vos, Erwin G Zoetendal, Cyriel Y Ponsioen
AIM: To study the clinical efficacy and safety of Fecal microbiota transplantation (FMT). We systematically reviewed FMT used as clinical therapy. METHODS: We searched MEDLINE, EMBASE, the Cochrane Library and Conference proceedings from inception to July, 2013. Treatment effect of FMT was calculated as the percentage of patients who achieved clinical improvement per patient category, on an intention-to-treat basis. RESULTS: We included 45 studies; 34 on Clostridium difficile-infection (CDI), 7 on inflammatory bowel disease, 1 on metabolic syndrome, 1 on constipation, 1 on pouchitis and 1 on irritable bowel syndrome (IBS)...
May 7, 2015: World Journal of Gastroenterology: WJG
Miguel Saps, Harman S Biring, Cenk K Pusatcioglu, Stijn Mintjens, Damian Rzeznikiewiz
OBJECTIVES: Abdominal pain-predominant functional gastrointestinal disorders (AP-FGIDs) are the most common cause of consultation to pediatric gastroenterology; however, no medications have been approved to treat this group of disorders in children. The Food and Drug Administration have published recommendations for clinical trials on AP-FGIDs in adults but not in children. The lack of methodological guidelines and accepted primary endpoints for clinical trials in children hampers the progress of the field, making the approval of new medications difficult...
May 2015: Journal of Pediatric Gastroenterology and Nutrition
Nasir Khokhar, Muhammad Omar Qureshi, Shafiq Ahmad, Aiza Ahmad, Hamza Hassan Khan, Farzana Shafqat, Muhammad Salih
BACKGROUND: Rifaximin has been used for prevention of recurrence of hepatic encephalopathy in twice a day dosage. The drug is expensive and lower dising may be possible. OBJECTIVE: To determine the efficacy of rifaximin once a day dose in the prevention of hepatic encephalopathy (HE) in patients with liver cirrhosis as compared with twice daily dose of rifaximin. METHODS: This Randomized control trial was carried out at the Department of Gastroenterology and Hepatology, Shifa International Hospital, Islamabad, Pakistan from November 2012 to February 2014...
September 2015: Journal of Gastroenterology and Hepatology
Sylvia Cruchet, Raquel Furnes, Aldo Maruy, Eduardo Hebel, Jorge Palacios, Fernando Medina, Nelson Ramirez, Marina Orsi, Lysette Rondon, Vera Sdepanian, Luis Xóchihua, Manuel Ybarra, Roberto Arturo Zablah
OBJECTIVE: The stability and composition of intestinal flora plays a vital role in human wellbeing throughout life from as early as birth. Over the past 50 years, several studies have been conducted to evaluate the effect of probiotic administration in pediatric gastroenterology. This document aims to provide a recommendation score on probiotic utilization in pediatric gastroenterology, together with a review of current knowledge concerning its benefits, tolerability, and safety. STUDY DESIGN: Published literature was selected without study design restriction: clinical guidelines, meta-analyses, randomized controlled trials (RCTs), cohort studies, outcomes research and case-controlled studies were selected using the following MESH-validated terms: probiotics, diarrhea, acute diarrhea, antibiotic-associated diarrhea, traveler's diarrhea, bacterial diarrhea, nosocomial diarrhea, prophylactic diarrhea, Helicobacter pylori infection, colic, infantile colic, necrotizing enterocolitis (NEC), inflammatory bowel disease, constipation, and allergy...
June 2015: Paediatric Drugs
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