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216 active trials for Crohn Disease

Permacol Paste in Perianal Crohn's Disease

The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.

Start: February 2019

AR-Power Patient Powered Research Network

ArthritisPower is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), and other musculoskeletal conditions. Participants will provide information from their smartphones or personal computers. The information will be used by researchers to help patients and their providers make better, more informed decisions about treatment of RA/SpA and other musculoskeletal conditions. ArthritisPower is part of a larger national research network called PCORnet whose 33 network members have mapped their data to a common data model. Network members will be able to submit queries through PCORnet in order to answer a range of comparative effectiveness research questions. Data sharing across PCORnet will be accomplished using secure methods to prevent patient identification. There is no cost to participants for participating and no compensation is provided. Objectives: To establish a research registry to enable comparative effectiveness research in rheumatic diseases and other musculoskeletal conditions. All data collected using the ArthritisPower mobile app as part of a subject's use is stored with the ArthritisPower registry. This data will be used in conjunction with existing and future research studies. To use the data from this study to improve treatment and to further advance finding a cure for rheumatic diseases.

Start: April 2015

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

Start: November 2020

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.

Start: September 2019

Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid

In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) or red-light (630 nm) photopheresis in patients with active crohns disease. The study is a proof-of-concept pilot with 10 included patients where every patient will get active treatment. The first 5 patients will receive blue light and the remaining 5 patients will receive red light. The use of 5-aminolevulinic acid in combination with blue-light and red-light photopheresis is a first-in-human trial. Primary endpoints include clinical response and adverse events (safety). Secondary endpoints include endoscopic improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and mechanisms of action (differences in t-cells and other cells before and after treatment). All patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with evaluation at week 13. If any effect on week 13 eligible for study extension with treatment every 4 weeks for up to 12 months. Through the study the investigators will see if this kind of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In addition the investigators will see if photopheresis as an option can be further developed for other diseases as well (ie other T-cell mediated diseases or patients already receiving photopheresis as a treatment).

Start: November 2019

Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Start: February 2019

Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.

Start: July 2020

Subjective Near-infrared Fluorescence Guidance in Perfusion Assessment of Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. The intraoperative imaging findings are then analysed and correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Start: February 2019

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Start: March 2020

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

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.

Start: November 2020

A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients

This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease (CD) in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' (pre-diet) in terms of its ability to change the gut bacteria and fecal butyrate, an important short-chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of this debilitating disease.

Start: November 2019

Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease

The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children. 150 children newly diagnosed with Crohn's disease will participate in the study and their data will be used to create an algorithm about their microbiome, disease, diet, etc. 100 other children newly diagnosed will participate in the study and their data will be use to validate the algorithm. The investigators will be recruiting 50 healthy participants: 20 that are undergoing an endoscopy for abdominal pain and 30 that comes to the physician for different reasons. After parental consent, the participants will receive an explanation of the study and sign a consent form for colonoscopy. Before colonoscopy, participants will bring fecal samples, give blood samples, biopsies and biopsy brushes (superficial scraping of the tissue) will be taken during the operation. These samples will be retained until further consent is obtained for further study. After receiving the results of the colonoscopy, children who have been diagnosed with Crohn's disease will be offered to participate in the second part of the study, they will receive an explanation about the app, collection of fecal samples at home, diet logs and anthropometric measurements, demographic information, medical and family history will be registered. During the first 3 months: the participants will be asked to log data in the app and collect fecal samples at home. They will be asked to come for a follow up visit where anthropomorphic measurements and blood samples will be taken. Participants will be asked to log in every day to report in the app daily activity and food intake throughout the study period. Each week, the research coordinator will call on participants to make sure the app is correctly filled in, collect the stool samples correctly and answer questions. During the entire study participants will collect fecal samples, every first week of the month participants will enter information in the app. For children who have not been diagnosed with Crohn's disease by the colonoscopy, or children who visit the institute for reasons other than inflammatory bowel disease without a clear finding will participate in the study control group. If consent is given, fecal samples will be collected at the entrance of the study and after one year, blood samples, a food questionnaire and anthropometric indices, demographic information, medical and family history will be completed.

Start: November 2020

Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Start: December 2018

Colorectal Cancer in Crohn's Disease

Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset. Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible. The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR). Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).

Start: July 2020

Biomarkers to Predict and Monitor Response to Infliximab

The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.

Start: November 2019

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

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

Start: July 2020

Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis, affects more than 1.6 million people in the United States alone. Despite current therapies, remission only occurs in approximately half of patients. The goal of study is to map single-cell spatial relationships across the spectrum of ileum/ascending colon from healthy control patients to uninvolved/quiescent and involved/active CD patients and assess for relationships between single-cell data and patient clinical data. The investigators will utilize endoscopic mucosal biopsies and surgical resection specimens with rapid transfer of fresh tissue to the single-cell preparation for RNA-sequencing and use of tissues for RNA-fluorescence in situ hybridization and multiplex immunofluorescence. Along with machine learning image analysis and bioinformatics, this will generate a robust/detailed single-cell gut cell atlas (GCA) of ileo-colonic CD at all disease activities versus normal tissues. The study will also compare the results of endoscopic mucosal biopsies to those obtained from full thickness surgical specimens by utilizing the Cooperative Human Tissue Network (CHTN). The investigators anticipate the GCA data will provide new insights into disease pathogenesis, leading to new therapeutic targets.

Start: December 2019

Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis

Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. During the last 25 years, the incidence of IBD has increased dramatically among teenagers in northern France, with an increase of 126% and 156% for CD and UC, respectively. Physical fitness is a set of attributes related to a person's ability to perform physical activities that require aerobic capacity, endurance, strength or flexibility and is determined by a combination of regular physical activity and genetically inherited ability. Physical fitness, widely recognised as an important health determinant, plays an important role in growth and development. Due to the evidence-based importance of physical fitness for young people's health status, attention should be paid to the assessment of physical fitness at these ages and whatever the health status. At this time, there is no study on the assessment of physical fitness in IBD pediatric patient.

Start: December 2020

Rifaximin in Patients With Diabetic Gastroparesis

Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.

Start: June 2019

Improving the Health Care in Inflammatory Bowel Disease.

Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.

Start: May 2016