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Crohn Disease clinical trials

View clinical trials related to Crohn Disease.

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NCT ID: NCT03173144 Completed - Psoriasis Clinical Trials

Chronic Inflammatory Disease, Lifestyle and Treatment Response

BELIEVE
Start date: September 21, 2017
Phase:
Study type: Observational [Patient Registry]

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and lifestyle is assumed to affect the treatment outcome. However, little is known on the effects of lifestyle as a prognostic factor (possibly enabling personalised medicine). The aims of this multidisciplinary collaboration are to identify lifestyle factors that support individualised forecasting of optimised treatment outcome on these costly drugs. This prospective cohort study will enrol CID patients assigned for biologic treatment. At baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome measures and clinical assessments on disease activity, quality of life, and lifestyle together with registry data on comorbidity and medication. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with specific lifestyle characteristics. The overarching goal of this project is to improve the lives of patients suffering from CID, by providing evidence to support dietary recommendations likely to improve the clinical outcome. The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

NCT ID: NCT03171246 Completed - Crohn Disease Clinical Trials

CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

Crohn's disease (CD) is a chronic inflammatory condition of the gut with severe complications. There is strong evidence to suggest that diet and gut bacteria are key components in the onset, perpetuation and management of CD. An 8-week exclusive liquid diet (EEN) without any normal food is the best treatment for paediatric CD. The mode of action of EEN remains unknown, but according to recent publications, the modulation of the gut bacteria drives its therapeutic properties. While successful, EEN is a challenging therapy to follow. Half of the paediatric EEN patients will require a nasogastric tube to support treatment, its use in adults is limited, and the need for a more palatable diet is very well described. Based on these findings, a non-liquid and more acceptable dietary treatment was recently devised called CD-TREAT (Crohn's Disease TReatment-with-EATing) diet. CD-TREAT, which is a solid food-based diet designed to replicate the nutrients and food ingredients composition of EEN, was recently tested in healthy adults and a rat model of colitis. In order to pilot CD-TREAT diet as a CD induction treatment, 10 children and 10 adults with active luminal CD will be recruited. Once consented, baseline blood, urine and faecal samples will be collected and the CD-TREAT prescribed for a maximum of 12 weeks. Another 3 blood, urine and faecal samples will be requested during the 12 weeks. All the foods/meals of the CD-TREAT diet will be purchased and delivered to the participants' house by the researcher and the meals which need cooking will be pre-prepared by a sub-contracted catering company. Blood and faecal inflammatory biomarkers will be measured, the disease activity assessed with routinely used clinical indices and the faecal bacteria and its metabolites characterised.

NCT ID: NCT03161886 Completed - Clinical trials for Inflammatory Bowel Diseases

A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

PCE
Start date: December 1, 2014
Phase: N/A
Study type: Interventional

This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.

NCT ID: NCT03155945 Completed - Crohn's Disease Clinical Trials

Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

Start date: July 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.

NCT ID: NCT03143517 Completed - Ulcerative Colitis Clinical Trials

Fecal Calprotectin Collection Protocol

CALFE
Start date: April 19, 2017
Phase:
Study type: Observational

The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.

NCT ID: NCT03138655 Completed - Ulcerative Colitis Clinical Trials

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: November 8, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.

NCT ID: NCT03134586 Completed - Crohn Disease Clinical Trials

Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

ANDI
Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

NCT ID: NCT03107793 Completed - Crohn Disease Clinical Trials

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

STARDUST
Start date: April 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.

NCT ID: NCT03105128 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Start date: May 10, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

NCT ID: NCT03104413 Completed - Crohn's Disease Clinical Trials

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Start date: December 18, 2017
Phase: Phase 3
Study type: Interventional

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.