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191 active trials for Inflammatory Bowel Diseases

Cytokines and Genes in Therapeutic Response in Crohn's Disease

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. At present, there are no reliable mechanisms to predict response to individual IBD medications. The investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. In addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.

Start: October 2017

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.

Start: January 2020

Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain. Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or discomfort, gas, loose and frequent stools. Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. The investigator proposes to investigate the effect of a microencapsulated form of sodium butyrate on the fecal microbiota of patients with IBD and IBS-D.

Start: June 2020

A Self-compassion Intervention for Parents of Children With Inflammatory Bowel Disease (IBD)

Parenting a child with Inflammatory Bowel Disease (IBD) can understandably be challenging and distressing at times. The aim of this study is therefore to investigate the effectiveness of an online self-compassion intervention (SCI), that focuses on helping individuals respond to themselves in a kinder and more accepting way, for parents of children with IBD. Around 150 parents of children with IBD will be randomly allocated to receive either the online SCI or a control condition. This will involve an initial administration and a two-week follow-up period. Participants will complete outcome measures of self-compassion, distress and shame at three time points. We hypothesise that, in comparison to a control group, participants receiving the online SCI will: (1) report increased state self-compassion and reduced state shame and distress immediately following the SCI; and (2) report increased trait self-compassion and reduced parental stress after repeated engagement in the SCI materials for two weeks. Through understanding the effectiveness of an online SCI for parents of children with IBD, we hope that our research will help to inform and improve parental support offered to parents of children with IBD.

Start: April 2021

Group Cognitive Behavioral Therapy for IBD Patients

Inflammatory bowel disease (IBD) patients commonly suffer from disturbed psychosocial functioning and poor quality of life compared to other chronic disease patients. Clinicians are becoming growingly aware that addressing patients' psychological difficulties may improve disease management, however, there is not adequate evidence regarding the effect of psychotherapeutic interventions on psychosocial functioning and disease-related clinical and laboratory parameters. The aim of the present study is the evaluation of the effects of a targeted, cognitive behavioral psychotherapeutic intervention on symptom severity, levels of psychological distress and quality of life and inflammation and disease activity indices in IBD patients. An additional aim is the detection of psychological and biomedical parameters which may be associated with these effects.

Start: February 2019

Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century

Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.

Start: June 2021

Regulation of Mucosal Healing in Inflammatory Bowel Disease

The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.

Start: April 2021

Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease

The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.

Start: December 2019

Fermented Food-Supplemented Diet in Ulcerative Colitis

The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.

Start: September 2020

Safety and Feasibility of ActivSightTM in Human

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

Start: November 2020

A Pilot and Feasibility Trial of a Group Mindfulness and Self-compassion Intervention for Young People Diagnosed With IBD

Young people with IBD face all the usual complexities of growing up, with the additional complications of having a chronic health condition, often recently diagnosed, which can have a detrimental impact on their mental health. This research seeks to examine the potential effectiveness of a two-stage intervention for young people with IBD via a pilot feasibility trial. First, a mindfulness-based stress reduction (MBSR) group with a "Mindfulness based compassionate living" (MBCL) group delivered soon afterwards. Both interventions will be delivered online. MBSR aims to increase peoples awareness of their tendency to get caught up in thoughts and help them live in the present moment. Once an individual has achieved greater awareness of their thought processes, MBCL then aims to help individuals to become kinder to themselves, and less critical. We know from interview studies with young people with IBD that they can be harsh on themselves about how they are coping, and being harsh and critical can impact wellbeing. By targeting mindfulness and self-compassion we hope to demonstrate a positive impact on wellbeing, by reducing stress, anxiety and depression and improving quality of life (primary outcome measures) for young people with IBD and equip them with a mindfulness practice to use in the future as they continue to manage their IBD.

Start: November 2019

VNS Prospective Neuromodulation of Autonomic, Immune and Gastrointestinal Systems

Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of efficacy is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune, gastrointestinal and autonomic systems. The primary objective of this study is to characterize the pre- and post-operative bowel habits and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre- and post-operative autonomic profile, (2) characterize the pre- and post-operative immune profile, and (3) to elucidate whether gut microbiota changes are related to VNS efficacy for epilepsy.

Start: April 2021

Intra-dermal With Topical Imiquimod Pretreatment Versus Intra-muscular Hepatitis B Vaccination in IBD Patients

Inflammatory bowel disease (IBD) has witnessed a rising incidence globally and in Hong Kong, an area where chronic hepatitis B (CHB) remains endemic. IBD patients are usually immunocompromised due to the disease itself and secondary to the use of medications including immunosuppressants and biologics, predisposing them to various opportunistic infection including hepatitis. Vaccination against hepatitis B virus (HBV) is recommended to prevent CHB and its related complications including flare up of acute hepatitis, cirrhosis and hepatocellular carcinoma. However, it is reported that efficacy with conventional intramuscular hepatitis B vaccination in IBD patients is suboptimal, especially among those receiving biologic therapies. Various strategies in boosting vaccine immunogenicity including the utilization of higher vaccination dose, shorter dosing interval, or alternate route of vaccine administration have been studied.6 Intradermal route of vaccination has been recently shown to be an effective way in augmenting immune response in specific patient groups who are known poor responders, including elderly and immunocompromised patients. In addition, topical imiquimod, a synthetic agonist of toll-like receptor 7 (TLR7), has been shown to further boost up the immunogenicity response when applied to the site before intradermal vaccination. The proposed study is the first clinical trial comparing the efficacy of intradermal hepatitis B vaccination with adjuvant topical application of imiquimod cream with the conventional intramuscular hepatitis B vaccination in IBD patients.

Start: August 2019

Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease

This is a prospective interventional study. The investigators will include patients in clinical remission who are on stable treatment. These IBD patients will be followed to analyze the effects of physical activity on their inflammatory disease. Different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.There will also be a control group that does not initially benefit from a specific physical activity program. However, this group will be integrated into one of the other two groups after the 10-week follow-up. All three groups will perform the same baseline tests. These will be of different types: physical tests, biological tests and quality of life questionnaires.

Start: January 2021

Digital Behavioral Interventions in Inflammatory Bowel Disease

Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.

Start: July 2021

Fertility and Pregnancy IBD Audit

Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.

Start: June 2021

A Diagnostic Accuracy Study Testing Fecal Biomarkers In Comparison To Endoscopic Examination

In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. The aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases. The following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.

Start: July 2020

Corrona Inflammatory Bowel Disease (IBD) Registry

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for IBD in a cohort of patients cared for by gastroenterologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Start: March 2017

Optical Coherence Tomography Angiography Assessment of Retinal Lesions in Inflammatory Bowel Diseases

Aim of the study;To record the vascular changes that may be present in the posterior segment of patients suffering from Inflammatory bowel diseases(IBD) using the optical coherence tomography angiography

Start: April 2021

Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission

In the 21st century, the incidence of inflammatory bowel disease (IBD) globally increases. Higher incidence of IBD development may implicate that environmental factors played essential roles in IBD pathogenesis. One of the environmental factors is a westernized diet that contains a high amount of animal protein and a low amount of dietary fiber. This kind of diet can lead to gut microbial dysbiosis and increase susceptibility to IBD. A microbial dysbiosis pattern in IBD is a decrease in microbial diversity and the inversed ratio of local protective and pathologic bacteria. High animal protein was associated with an increased risk of IBD and increased risk of disease relapse meanwhile dietary fiber was associated with IBD risk reduction. A semi-vegetarian diet is a diet with high fiber and low red meat and processed food that may reduce inflammatory activity in IBD. The study in the semi-vegetarian diet in IBD activity is still limited. This study aimed to evaluate a semi-vegetarian diet's effect in maintaining IBD remission in disease quiescence patients.

Start: January 2020