Active clinical trials for "Inflammatory Bowel Diseases"

While people of color are an increasing segment of the inflammatory bowel disease (IBD) population, they are currently underrepresented in research, including studies of psychological distress. Appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of IBD activity has led to increased efforts to integrate psychological interventions into IBD medical care. Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. There are unanswered questions in the use of CBT in IBD: how to leverage digital technology to deliver CBT through internet-based cognitive behavioral therapy (iCBT); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? Thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with IBD and as racial or ethnic minority influence attitudes toward mental health and iCBT in a cohort of Black and Latino IBD patients with elevated psychological distress. Results will lead to adaptation of a CBT program into an iCBT app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.

Introduction: Fatigue is a serious symptom that is seen in a significant portion of IBD patients and negatively affects the patient's quality of life. The aim of this study is to evaluate the effect of patient education on the management of fatigue, which is common in inflammatory bowel diseases. Material and methods: This study will be planned with nonrandomized control group, pretest-posttest design. It is planned that the sample group will consist of at least 84 patients, 42 of which are in the intervention group and 42 in the control group. The patients in the intervention group will be evaluated in terms of fatigue and factors that may affect it, and an individualized education program will be offered according to the needs of the patient.For the patients in the control group, only the scales used in data collection will be filled, and no education will be planned. One month after the first interviews, both groups will fill in the scales again.

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes. About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.

Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.

ZL-82 is an oral janus kinase (JAK) inhibitor. In vitro biological mass spectrometry identification test proves that ZL-82 can selectively and irreversibly inhibit JAK3. It has obvious safety advantages, with a wide therapeutic window and controllable cardiotoxicity. This is also demonstrated from preliminary GLP-conditions of acute toxicity in SD rats and Beagle dogs. Results of 4-week long-term toxicity in Beagle dogs also support this notion. Therefore, ZL-82 has the potential to treat rheumatoid arthritis. It Used to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis.The drug is intended to be used in patients with RA to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis. Pharmacodynamic studies show that ZL-82 has a strong inhibitory effect on JAK3 with IC50 of 2.8 nM, and has no obvious inhibitory effect on JAK1, JAK2 and TYK2. Compared with the similar drug Tofacitinib, its inhibitory effect on JAK3 subtype is 1nM, but its inhibition IC50 for JAK1 subtype and JAK2 subtype are 112nM and 20nM, respectively.and its selectivity is 100-fold and 20-fold, respectively.Also, the selectivity multiples of ZL-82 were 100-fold and 20-fold than tofacitinib , respectively, which indicates that ZL-82 is more selective than the marketed Tofacitinib.This allows ZL-82 to precisely inhibit JAK kinase and block a series of cytokines in the downstream signaling pathway. And show significant effect on rheumatoid arthritis. The experimental results showed that in DTH and CIA models, 25, 50, 75, and 100 mg/kg of this variety could dose-dependently inhibit joint swelling in mice. Objectives of Study Main Purpose: To evaluate the tolerability, safety and pharmacokinetic characteristics of a single oral dose of ZL-82 tablets in healthy adult subjects; To explore the effect of eating on the PK of oral ZL-82 tablets in healthy adult subjects; To evaluate the tolerability, safety and pharmacokinetics of ZL-82 tablets after multiple oral administration in healthy adult subjects.

Secreted bacterial effectors produced by the intestinal microbiota are in part responsible for the proinflammatory effect of the fecal content in inflammatory bowel disease (IBD) patients.

A comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering IBD and BH care. Quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.

The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are lacking. The Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery, which has the short title "ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US)," study is a multicenter, pragmatic, prospective study, using a stepped wedge cluster randomized controlled trial design. The study is designed to test the adoption, effectiveness, and generalizability of a newly developed, 21-element ERP for children undergoing elective gastrointestinal surgery.

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.