Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
Crohn DiseaseRecurrenceThe postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Inflammatory Bowel DiseasesCrohn Disease1 moreInterventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
Rifaximin in Patients With Diabetic Gastroparesis
Crohn DiseaseDiabetic GastroparesisResearchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.
Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision...
Postoperative Surgical RecurrenceThe study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance...
Inflammatory Bowel DiseasesCrohn Disease1 moreRandomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.
TDM Guided Early Optimization of ADAL in Crohn's Disease
Crohn DiseaseDrug Monitoring1 moreTo investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
InsomniaCrohn DiseaseThe purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.
The Nordic IBD Treatment Strategy Trial
Inflammatory Bowel DiseasesUlcerative Colitis1 morePurpose: To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes. Objectives: Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Study design: A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice. Study population: Newly diagnosed IBD patients. Number of subjects:250 Primary variables: Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure. Ulcerative colitis; Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0. Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g Crohn's disease; Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline. Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.
Induction Optimization With Stelara for Crohn's Disease
Crohn DiseaseThis is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety...
Crohn DiseaseThis is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.