scholarly journals A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease

Gut ◽  
2004 ◽  
Vol 53 (11) ◽  
pp. 1639-1645 ◽  
Author(s):  
A P Kennedy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomised Controlled Trial ◽  
Bowel Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Chronic Inflammatory Bowel Disease ◽  
Management Approach ◽  
Inflammatory Bowel ◽  
Randomised Controlled ◽  
Chronic Inflammatory Bowel

scholarly journals Control Crohn Safe with episodic adalimumab monotherapy as first-line treatment study (CoCroS): study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e042885
Author(s):  
Laura Janssen ◽  
Mariëlle Romberg-Camps ◽  
Ad van Bodegraven ◽  
Jeoffrey Haans ◽  
Michèl Aquarius ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomised Controlled Trial ◽  
Bowel Disease ◽  
Controlled Trial ◽  
Chronic Inflammatory Bowel Disease ◽  
Close Monitoring ◽  
Disease Course ◽  
Study Results ◽  
Inflammatory Bowel ◽  
Randomised Controlled

IntroductionCrohn’s disease (CD) is a chronic inflammatory bowel disease with a heterogeneous clinical presentation, relapse rate and treatment response. At present, no markers are available to adequately predict disease course at diagnosis. To prevent overtreatment of patients with a relative mild disease course, a step-up approach starting with corticosteroids is usually applied. Timely introduction of potentially disease modifying drugs and tight control of mucosal inflammation are crucial to prevent disease-related complications in patients with a complex disease course. We hypothesise that episodic treatment with adalimumab monotherapy in combination with close monitoring after drug discontinuation improves long-term outcome and reduces drug-related side effects, while preventing overtreatment.Methods and analysisIn this pragmatic multicentre randomised controlled trial, newly diagnosed CD patients or CD patients with a flare, naïve to thiopurines and biologicals, will be included and randomised 1:1 to open-label episodic (ie, 24 weeks) adalimumab monotherapy or step-up care starting with corticosteroids. The primary outcome is the number of yearly quarters of corticosteroid free clinical (Monitor Inflammatory Bowel Disease At Home score ≤3) and biochemical (C reactive protein within normal range and faecal calprotectin ≤200 µg/g) remission at week 96. Secondary outcomes are total healthcare costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, corticosteroid-free clinical remission, time to remission and patient-reported outcome measures on quality of life, (work) disability and treatment adherence. Safety outcomes are drug-related and disease-related adverse events and disease progression on MRI-enterography at week 96.Ethics and disseminationThis study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 21 August 2019 (METC18-076) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.Trial registration numberNCT03917303.

scholarly journals Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036400
Author(s):  
Jérémy Vanhelst ◽  
Stéphanie Coopman ◽  
Julien Labreuche ◽  
Claire Dupont ◽  
Valérie Bertrand ◽  
...  
Keyword(s):  
Physical Activity ◽  
Inflammatory Bowel Disease ◽  
Randomised Controlled Trial ◽  
Bone Health ◽  
Bowel Disease ◽  
Controlled Trial ◽  
Whole Body ◽  
Paediatric Patients ◽  
Inflammatory Bowel ◽  
Randomised Controlled

IntroductionLow bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.Methods and analysisThis trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.Ethics and disseminationThe study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union’s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.Trial registration numberNCT03774329.

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