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Crohn Disease clinical trials

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NCT ID: NCT05652491 Withdrawn - Ulcerative Colitis Clinical Trials

The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease

Start date: December 9, 2022
Phase:
Study type: Observational

Background: Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation. Imbalances in the gut microbiome have been linked to illnesses such as inflammatory bowel disease (IBD). People diagnosed with IBD can have serious health problems. Researchers want to know more about how the gut microbiome affects the development and progression of IBD in children. In this natural history study, they will compare the gut microbiomes of healthy children with those who have IBD. Objective: To collect stool and samples of intestine tissue from children with and without IBD undergoing colonoscopy. Eligibility: People under 21 years old who are having a colonoscopy at the Inova Health System or Pediatric Specialists of Virginia. Design: Participants will fill out a questionnaire. They will answer questions about their history. Topics may include how they were fed as infants; how they were born; and how often they took antibiotics. Stool and tissue samples from the intestines will be taken during the participants colonoscopy. They may also give samples of blood and urine. Participants may be asked to provide additional stool, blood, and urine samples. They may do this up to 3 times per year. These samples may be collected at the clinic; they may also be collected at home and mailed to the researchers. If they have more colonoscopies, participants may be asked for more tissue samples. Participants will be enrolled for up to 10 years. ...

NCT ID: NCT05578508 Withdrawn - Crohn's Disease Clinical Trials

Stem Cells for the Treatment of Pouchitis

Start date: April 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.

NCT ID: NCT05471492 Withdrawn - Crohn Disease Clinical Trials

Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease

Start date: July 30, 2023
Phase: Phase 2
Study type: Interventional

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity

NCT ID: NCT05246943 Withdrawn - Colorectal Cancer Clinical Trials

The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

Start date: May 25, 2022
Phase:
Study type: Observational

The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

NCT ID: NCT05104229 Withdrawn - Ulcerative Colitis Clinical Trials

SAVES-IBD: Safety & Efficacy of Aspirin vs. Standard of Care for VTE Prophylaxis After IBD Surgery

SAVES-IBD
Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

Aim to determine if aspirin 81 mg orally twice daily is effective and safe as an extended VTE chemoprophylaxis agent after major abdominal surgery for IBD patients. Study will perform an open label trial of aspirin for VTE prophylaxis compared standard of care.

NCT ID: NCT05057273 Withdrawn - Crohn's Disease Clinical Trials

Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

Start date: November 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

NCT ID: NCT05028946 Withdrawn - Crohn's Disease Clinical Trials

A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease

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

The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).

NCT ID: NCT04982666 Withdrawn - Crohn Disease Clinical Trials

Whole-Food, Plant-Based Diet for Active Crohn's Disease

Start date: April 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the ability of a whole-food, plant-based (WFPB) diet to produce symptomatic remission in Crohn's Disease patients.

NCT ID: NCT04944797 Withdrawn - Crohn Disease Clinical Trials

Crohn and Anal Incontinence

CRIA
Start date: March 30, 2022
Phase:
Study type: Observational

Anal incontinence affects nearly 5% of the adult population in France. It is defined as the inability for a subject to retain matter and/or gas, outside of voluntary defecation episodes. It results in an uncontrolled loss of gas or stool through the anus. To quantify, anal incontinence clinical scores have been developed of which the most used is the Cleveland score (Jorge and Wexner). A Cleveland score ≥ 5 corresponds to anal incontinence. Crohn's disease is a chronic inflammatory disease that can affect the entire digestive tract as well as the anus. It leads to destruction of the intestinal wall if not treated early. The presence of ano-perineal involvement is a factor of severity and poor prognosis of Crohn's disease. The management of these ano-perineal lesions is particularly difficult because of the risks of destruction of the anal sphincter and recurrence of these lesions, as well as the consequences that they induce on anal continence, sexuality and quality of life. The prevalence of anal incontinence in Crohn's disease has been assessed in three studies by self-questionnaires. In 2013, it was studied in a cohort of British patients followed for chronic inflammatory bowel disease (IBD) (Hemorrhagic rectocolitis or Crohn's disease). Of the 3264 patients who responded to this questionnaire (32.5% of the cohort), 74% claimed to have anal incontinence and in 40% of cases it occurred regularly or a few times. In a study of 184 patients treated at an IBD expert center in Sri Lanka, anal incontinence was reported to be 26%. Only 5 patients reported regular anal incontinence. Vollebregt et al specifically studied the prevalence of anal incontinence in patients followed for Crohn's disease in a Dutch expert center. Of the 325 responses (62%), 20% of patients reported having had an episode of anal incontinence in the last 4 weeks. In these studies, the prevalence of anal incontinence varies according to the definition of anal incontinence (qualitative or quantitative estimate) and the population studied. No French study has been published on the prevalence of anal incontinence in Crohn's disease.

NCT ID: NCT04795960 Withdrawn - Crohn Disease Clinical Trials

Microbiome Modification to Enhance Stelara Response in Crohn's Disease

MIM-TESRIC
Start date: March 18, 2021
Phase: N/A
Study type: Interventional

This pilot study is being completed to determine whether a low-serine diet vs a high serine diet will reduce inflammation and symptoms in Crohn's disease (CD), as well as determine whether a low-serine diet (vs. a high serine diet) will improve responses in patients initiating therapy with Ustekinumab (Stelara), an FDA-approved biologic therapy for Crohn's disease.