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Crohn Disease clinical trials

View clinical trials related to Crohn Disease.

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NCT ID: NCT05072782 Recruiting - Crohn Disease Clinical Trials

Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)

POMEROL
Start date: December 21, 2021
Phase: Phase 4
Study type: Interventional

Study type : A 30 months, multicentre, open-label strategic randomized controlled trial Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection). Treatments : Stratification at inclusion according to prophylactic therapy. Patients randomized in 2 arms: - Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose. - Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards. Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.

NCT ID: NCT05057832 Recruiting - Crohn Disease Clinical Trials

Determination of Ustekinumab Levels in Patients With Crohn's Disease

Ustekinumab
Start date: May 1, 2021
Phase:
Study type: Observational

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

NCT ID: NCT05043870 Recruiting - Crohn Disease Clinical Trials

Combined Immunosuppression for Pediatric Crohn's Disease

Start date: October 10, 2022
Phase: Phase 4
Study type: Interventional

This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.

NCT ID: NCT05040464 Recruiting - Crohn Disease Clinical Trials

Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

COMET
Start date: August 26, 2021
Phase: Phase 3
Study type: Interventional

Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety. The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.

NCT ID: NCT05039411 Recruiting - Fistula in Ano Clinical Trials

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease

Start date: March 1, 2022
Phase: Phase 1
Study type: Interventional

Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).

NCT ID: NCT05009212 Recruiting - Crohn Disease Clinical Trials

Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

DESTRESS
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation. However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.

NCT ID: NCT04998084 Recruiting - Ulcerative Colitis Clinical Trials

Advanced Therapy Registry of IBD Patients

Start date: February 28, 2019
Phase:
Study type: Observational

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

NCT ID: NCT04997733 Recruiting - Crohn Disease Clinical Trials

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

MIRACLE
Start date: September 22, 2021
Phase: Phase 3
Study type: Interventional

Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts. The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.

NCT ID: NCT04976491 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Based on the Special Disease Management of Crohn's Disease Diet Studies

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

This project plans to develop a new diet therapy suitable for China -- CD-C-food, which is more in line with the common diet of Chinese patients' eating habits and economic conditions, and its expected therapeutic effect and influence on intestinal microorganism are similar to that of EEN. In order to explore the influence of intestinal microorganisms and their metabolites on the clinical remission effect and inflammatory response of patients with CD-C-Food, and to reveal the possible internal mechanism, a randomized control of adult subjects with a healthy CD-Chinese-food diet, treatment group of CD patients and animal model will be conducted by using intestinal microbiome, bacterial metabolite analysis, inflammatory factors detection and other technical means.

NCT ID: NCT04974099 Recruiting - Crohn Disease Clinical Trials

Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease

REMODEL
Start date: October 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease, with many of those being young children and adolescents. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that formulates a dose based on a patient's blood testing results can better achieve the optimal drug level as compared to standard dosing.