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IBD clinical trials

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NCT ID: NCT03366090 Recruiting - Ulcerative Colitis Clinical Trials

Immunological Profiles in Inflammatory Bowel Disease

ImmunoIBD
Start date: October 1, 2017
Phase: N/A
Study type: Observational

Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.

NCT ID: NCT03291743 Terminated - Crohn Disease Clinical Trials

The Biologic Onset of Crohn's Disease: A Screening Study in First Degree Relatives

Start date: February 10, 2017
Phase: N/A
Study type: Interventional

Pursuing very early diagnosis is standard of care for several diseases including colon cancer, diabetes and liver disease where an early and aggressive diagnostic and therapeutic approach has been shown to change their natural history. Crohn's disease [CD] still lags since commonly at presentation CD has already run a long course, often responding poorly to therapy or requiring surgery. This innovative project proposes a minimally invasive strategy - capsule endoscopy-based screening of first degree relatives [FDR's] of CD patients - to develop tools to diagnose CD at or near its biologic onset.

NCT ID: NCT03162432 Active, not recruiting - Ulcerative Colitis Clinical Trials

High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade

Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.

NCT ID: NCT03145896 Not yet recruiting - IBD Clinical Trials

The Correlation Between Anemia of Chronic Diseases, Hepcidin and Vitamin D in IBD Patients

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Crohn's disease (CD) and ulcerative colitis (UC) are chronic gastrointestinal diseases characterized by relapsing and remitting inflammation of the intestines Anemia may often complicate the course of inflammatory bowel disease (IBD). The cause of anemia in IBD is multifactorial In the chronically ill patients, it has been described that the mechanism underlying anemia involves hepcidin.A potential mechanism underlying anemia during an chronic disease is suggested by recent data demonstrating a hepcidin lowering effect of vitamin D

NCT ID: NCT03116568 Active, not recruiting - Pregnancy Related Clinical Trials

Bacterial Transmission In Utero and IBD Risk

Start date: April 24, 2017
Phase:
Study type: Observational

Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses. Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us to understand the change of bacterial composition human microbiome in the gut during pregnancy and childhood development.

NCT ID: NCT02970149 Recruiting - IBD Clinical Trials

Identifying a Sleep Screener for Disease Relapse in Children With Inflammatory Bowel Disease

Start date: November 2016
Phase: N/A
Study type: Observational

Background: Inflammatory bowel disease (IBD) is a group of disorders characterized by chronic inflammation of the gastrointestinal tract with remissions and relapses. The two most common subtypes are Crohn's disease (CD) and ulcerative colitis (UC). In 2012, the burden-of-illness report from the Crohn's and Colitis Canada estimated that the direct medical costs of IBD in Canada were over one billion dollars, primarily funded through the Canadian public healthcare system. Many life style-related factors may play an important role in the pathogenesis of IBD and can contribute to trigger disease relapse, but several of these factors are poorly understood. These factors may include sleep disturbances. Data on sleep disturbance in children with IBD are limited. Sleep deprivation has been shown to cause reactivation of colitis in animal studies but similar data are lacking in humans especially in children. Hypothesis: In children with IBD, high scores for a sleep disturbance screener will be positively associated with IBD relapse Objective: To develop a non-invasive non-costly tool to screen for relapses in pediatric IBD patients through examining the association between sleep disturbances and disease relapse in children with IBD Methods: This study will incorporate an observational prospective design. Participants: Participants will be 90 children (ages 8-17 years ) under the care of the Pediatric IBD Program at the Children's Hospital, Winnipeg. All participants will have an established diagnosis of IBD. Measures: Sleep disturbances will be assessed using a sleep diary. Patients will be asked complete a daily sleep diary in the week preceding their clinic appointment. The sleep diary will provide information about latency to fall asleep, number of awakenings, duration of awakenings, total sleep time, sleep quality, and sleep efficiency. Mucosal inflammation will be assessed by measuring fecal calprotectin and clinical disease activity will be measured Pediatric Crohn's disease activity index (PCDAI) for CD and pediatric ulcerative colitis activity index (PUCAI) for UC at clinic visits Anxiety/Depression: As anxiety and depression are often comorbid with disturbed sleep, levels of symptoms in both domains will be assessed at clinic visit using the Child and Parent Report Versions of the Spence Anxiety Scale and the Child Depression Inventory (v. 2). Procedure: Upon obtaining informed consent, each participant will complete 7 days of sleep diary recording in the week prior to their clinic appointment. During the clinic visit, the PCDAI or PUCAI, Spence Anxiety Scales, Child Depression Inventory will be completed. Fecal samples will be collected for fecal calprotectin measurement as a surrogate marker for mucosal inflammation. Other investigations will include blood samples for serum hemoglobin, serum albumin, and inflammatory markers. Stool samples for infection screen will also be collected to exclude any possibility for gastrointestinal infection on top of IBD.A second clinic visit will be scheduled 3 months later and the whole process will be repeated in the second visit. Regression analysis will be performed to examine the association between sleep disturbances and disease activity, characteristics and patients' demographics Outcomes: Primary outcome: Cut-off score of a sleep screener that is associated with disease relapse (as diagnosed by fecal calprotectin value of >100 microgram/gram of stools) in children with IBD Secondary outcomes: 1. Correlation between sleep disturbance scores and clinical disease activity indices (PCDAI and PUCAI). 2. Identification of which sleep component (sleep duration, latency, fatigue, subjective quality) is the best at detecting a disease relapse. 3.Identification of whether sleep disturbance more accurately predicts relapse for CD than for UC.

NCT ID: NCT02914262 Completed - IBD Clinical Trials

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers

Start date: August 2016
Phase: Phase 1
Study type: Interventional

This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.

NCT ID: NCT02694588 Completed - IBD Clinical Trials

Clinical and Molecular Phenotyping in IBD

Phen_IBD
Start date: June 2014
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses. Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.

NCT ID: NCT02622139 Completed - Ulcerative Colitis Clinical Trials

Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)

MSOT_IBD
Start date: November 2015
Phase: N/A
Study type: Interventional

Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.

NCT ID: NCT02619552 Completed - Crohn's Disease Clinical Trials

Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease

Start date: August 2011
Phase:
Study type: Observational

Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects. Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known. The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids. The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.