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Crohn Disease clinical trials

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NCT ID: NCT04623476 Recruiting - Crohn Disease Clinical Trials

PAtophysiological, Nodal-based Approach for Crohn's Disease Excision

PANACEAPILOT
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence. The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence. Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease). Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.

NCT ID: NCT04617184 Recruiting - Ulcerative Colitis Clinical Trials

Registry and Biorepository for IBD in Central Texas

Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.

NCT ID: NCT04612621 Active, not recruiting - Clinical trials for Crohn Disease of Intestine

MILESTONE-CD -A Prospective Multiomic Inception Real -Life Study To Evaluate Predictors of Disease Outcomes & respoNse to Biologic Treatment in Crohn's Disease

MILESTONE-CD
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least 30% of the patients. The course of disease is extremely diverse, ranging from a very mild disease to a devastating and incapacitating course. The burden of inflammatory bowel disease is growing each disease, reaching 400 billion USD for lifetime in US. In Israel, there are currently over 50000 IBD patients, with one of the highest incidences in the word, multiple treatment modalities and medications are available for Crohn's disease, however the efficacy is limited and the costs- very high. Furthermore, long-term exposure to some of the therapeutic agents poses an increased risk of infections and cancer. Some of the major challenges in IBD include prediction of disease course (some patients will require early and aggressive treatment while others may just need observation and follow-up), and treatment personalization (right drug for the right patient at the right time). Unfortunately, individualized predictors of disease course and response to treatment are currently very limited. Some clues can be derived from imaging and endoscopy data, transcriptomics, genomic and microbiome, however those are still very premature and impractical. Moreover, large-scale studies with sophisticated predictive models that incorporate multilayered and multilayered clinical and omic data are severely lacking.

NCT ID: NCT04606017 Completed - Crohn Disease Clinical Trials

Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease

Start date: January 1, 2014
Phase:
Study type: Observational

Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.

NCT ID: NCT04597905 Completed - Crohn Disease Clinical Trials

Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe

Start date: October 21, 2020
Phase:
Study type: Observational

The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.

NCT ID: NCT04596566 Active, not recruiting - Crohn Disease Clinical Trials

Modeling Patient Response to a Therapeutic Diet in Crohn's Disease

TDI
Start date: February 20, 2020
Phase: N/A
Study type: Interventional

BACKGROUND: There is an urgent need to understand the role of therapeutic dietary interventions on the treatment of inflammatory bowel disease (IBD). Although nutritional observational studies have examined associations between diet and the development of IBD, the relationship between dietary components and disease relapse is lacking. Despite the lack of a well-defined relationship between dietary determinants and disease relapse, patients with IBD frequently have a strong belief that diet has a key role in controlling the course of their disease, and maybe a trigger of disease relapse. This proposed randomized controlled trial (RCT) explores the efficacy of a Crohn's Disease (CD) Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate luminal CD. For asymptomatic patients with active disease, efficacy of the diet will be explored by using fecal calprotectin and sonographic findings Rationale: Our team of investigators recently compared a representative healthy population to patients with CD and identified CD patients have: lower intakes of polyunsaturated and monounsaturated fats and multiple micronutrients (vitamins C, D, thiamine magnesium, phosphorus, zinc, potassium), and; few patients with CD met criteria for an anti-inflammatory dietary pattern. Since the diet is a modifiable potential risk factor for disease recurrence in IBD, there is a strong rationale for the investigation of diet on disease course. Additionally, patients have expressed strong interest in identifying the relationships between diet and disease, therefore assigning priority to this theme is an opportunity to advance patient-oriented care.

NCT ID: NCT04590508 Recruiting - Crohn Disease Clinical Trials

A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease

XMaS
Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

A pilot study to assess the safety and tolerability of an orally administered natural product derived from hops, called xanthohumol, in humans with Crohn's Disease, in order to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature within adults with Crohn's Disease.

NCT ID: NCT04578392 Recruiting - Crohn Disease Clinical Trials

MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

SPARES
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years

NCT ID: NCT04573959 Completed - Crohn Disease Clinical Trials

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

NCT ID: NCT04567628 Completed - Crohn Disease Clinical Trials

Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes

VEDO TDM RWE
Start date: October 5, 2020
Phase:
Study type: Observational

The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).