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Crohn Disease clinical trials

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NCT ID: NCT03462875 Active, not recruiting - Crohn Disease Clinical Trials

The ENIGMA Study: Eastern Inflammatory Bowel Disease Gut Microbiota

Start date: August 29, 2018
Phase:
Study type: Observational

The incidence of inflammatory bowel diseases, (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), is increasing in the developing world. Our recent Asia-Pacific population-based study in 8 Asian countries and Australia has demonstrated that Hong Kong and China have amongst the highest disease incidences in Asia while Australia has the equal highest incidence of these diseases in the world. The ENIGMA project comprises three main enteric microbiome domains of central importance to Crohn's disease. Two specific organisms which may play a critical role in disease pathogenesis, including the candidate protective bacterium, and the novel pathogenic candidate, will be characterized and studied in detail. Microbial findings will be related to a detailed assessment of environmental factors that permit microbial changes or expression.

NCT ID: NCT03456206 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

Chronic Inflammatory Disease, Lifestyle and Risk of Disease

PROCID-DCH
Start date: November 10, 2018
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) and multiple sclerosis are diseases of the immune system that have some shared genetic and environmental predisposing factors, but still little is known on the effects of lifestyle as a prognostic factor on disease risk. This observational study will contribute to preexisting research on lifestyle factors by identifying diet factors associated with risk of developing CID, using prospective register data. The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register. The outcome CID is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018. The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses." The core study is an open register-based cohort study. The study does not need approval from the local Ethics committee or Institutional Review Board by Danish law. The study was approved by the Danish Data Protection Agency (2012-58-0018) Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

NCT ID: NCT03440372 Active, not recruiting - Crohn Disease Clinical Trials

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03397108 Active, not recruiting - Ulcerative Colitis Clinical Trials

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Start date: July 4, 2017
Phase:
Study type: Observational

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.

NCT ID: NCT03345823 Active, not recruiting - Crohn's Disease Clinical Trials

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

U-ENDURE
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT ID: NCT03340519 Active, not recruiting - Crohn Disease Clinical Trials

Early MRI Prediction of Crohns

Start date: December 17, 2018
Phase:
Study type: Observational

The investigators plan a prospective study designed to optimize and translate noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel Crohn's Disease (CD).

NCT ID: NCT03306446 Active, not recruiting - CD Clinical Trials

Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab

CURE
Start date: March 17, 2015
Phase: Phase 4
Study type: Interventional

This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.

NCT ID: NCT03285230 Active, not recruiting - Breast Cancer Clinical Trials

The French E3N Prospective Cohort Study

E3N
Start date: June 15, 1990
Phase: N/A
Study type: Observational

The French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.

NCT ID: NCT03266484 Active, not recruiting - Ulcerative Colitis Clinical Trials

Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

Start date: November 13, 2017
Phase: N/A
Study type: Interventional

The study is proposed as a single-site randomized double-blind placebo-controlled trial requiring 4 study visits, where two of the visits are combined with their appointment for routine clinical care. The study population will consist of patients with quiescent CD and UC and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible patients will be contacted at the time of their routinely scheduled office visit and consented for the study. Self-report and review of medical records will be used to obtain detailed information regarding their disease on an intake questionnaire completed by a research study coordinator. The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic supplement compared to placebo. We propose to examine the effect of a specific probiotic supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue symptoms in patients with quiescent IBD. Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline visit. The patient will receive either the probiotic supplement or placebo for 4 weeks. The first follow up visit will be at week 4 to check for adverse events on study treatment, to check accountability of probiotics/placebo, and to complete the set of questionnaires. Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment. At week 8, subjects will receive a phone call from a study research coordinator to check in with probiotics/placebo intake for treatment compliance and accountability records, and to complete the set of questionnaires ascertaining subjective symptoms. Last study visit will be at week 12 which is often combined with a regular office appointment. Subject will provide serum blood and stool sample, as well as complete the set of questionnaires.

NCT ID: NCT03261206 Active, not recruiting - Crohn Disease Clinical Trials

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

STATIC
Start date: November 20, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.