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IBD clinical trials

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NCT ID: NCT05689892 Not yet recruiting - Ulcerative Colitis Clinical Trials

Shared Decision Making in Paediatric Inflammatory Bowel Disease

SDM-IBD
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this mixed-methods prospective cohort study is to assess the impact of shared decision-making (SDM) on newly diagnosed pediatric inflammatory bowel disease (IBD) patients and their families. Patient and familial decisional conflict regarding the choice and course of treatment is shown to be high, especially for the newer class of IBD treatments called biologic agents. SDM intervention comprises of coaching with a decision coach (DC) on all aspects of treatment and care, along with educational decision aids (DA) provided and adapted from Cincinnati Children's Hospital Medical Center. The main aims of this study are: 1. to determine if SDM intervention has an impact on patient and parental decision making in pediatric IBD treatments, mainly by assessing decisional conflict and decision satisfaction/regret. 2. to adapt and assess the acceptability of DA in a Canadian academic center. Participants who have been recommended a new biologic as part of their clinical care for IBD will be recruited to the SDM intervention group. The participants will have DC sessions until a final treatment decision is made, will be given DAs, and will be followed by baseline and post-intervention surveys to assess decisional conflict and satisfaction/regret. The comparator group will include participants who have been recommended and have commenced a new biologic within the last 12 months. Outcome metrics will evaluate the impact on parental and patient decisional conflict following SDM intervention, and decisional satisfaction/regret 6-12 months from therapy start.

NCT ID: NCT05686135 Recruiting - Ulcerative Colitis Clinical Trials

90Second IBD for the Improvement of Self Efficacy and Quality of Life in Inflammatory Bowel Disease Patients

Start date: June 7, 2023
Phase: N/A
Study type: Interventional

Patients with Inflammatory Bowel Disease (IBD) have poorer quality of life than healthy people. Despite the high prevalence of psychological issues and its profound influence on quality of life, most IBD patients have limited access to mental health support. As well, many may decline support if it is offered because mental health is often not thought of as part of IBD care. Patients may be able to access cognitive behavioural therapy (CBT) through a psychologist, however this intervention is costly and requires considerable commitment on the part of person with IBD. There is a need for new methods of reaching IBD patients to provide information on their psychological needs, and normalize the psychological effects of IBD. These new methods should integrate medical issues with psychosocial issues while being effective, scalable, and low cost to the health care system. 90SecondIBD is a novel way of delivering health information about IBD using Persuasive Design technology embedded in a planned behavior model. This project will investigate the effect of the intervention "90SecondIBD", a weekly online health letter, on IBD patients' quality of life and self efficacy. Regression modelling will be performed to explore the ability of clinical and demographic factors to predict quality of life and self efficacy scores following receipt of 90SecondIBD educational health letters weekly for 6 months and 12 months.

NCT ID: NCT05624801 Recruiting - IBD Clinical Trials

Cholecalciferol in Chronic Inflammatory Bowel Diseases

5C
Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

In this research project, the investigators want to find out whether the additional intake of vitamin D further reduces the inflammatory events in the intestines of IBD patients. There are three groups of subjects: the 1st group takes a capsule of 24,000 IU per week, the 2nd group takes 24,000 IU per month, the 3rd group is the control group. The intake extends over 6 months during the autumn and winter period.

NCT ID: NCT05578768 Recruiting - IBD Clinical Trials

Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

PrePro
Start date: October 3, 2022
Phase:
Study type: Observational

The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.

NCT ID: NCT05474742 Terminated - Ulcerative Colitis Clinical Trials

The Nori Health App

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.

NCT ID: NCT05414955 Enrolling by invitation - IBD Clinical Trials

Boom-IBD Clinical Trial

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Feasibility study of neuromodulation in patients with IBD.

NCT ID: NCT05330299 Recruiting - Clinical trials for Psychological Distress

Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study

COMPASS-IBD
Start date: December 2, 2022
Phase: N/A
Study type: Interventional

This study is a single-centre, interventional implementation and feasibility study. Patients in the IBD service will be able to access COMPASS, an online cognitive-behavioural therapy (CBT) programme, as part of standard care at Guy's and St Thomas's NHS Foundation Trust. COMPASS is an online program. It will consist of 11 online modules which target challenges associated with living with IBD (and other long-term conditions) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 5-6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message).

NCT ID: NCT05246917 Recruiting - Crohn Disease Clinical Trials

Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

HAND2END
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction. DESIGN Randomised superiority study POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum INTERVENTION Kono S and end to end hand sewn anastomosis USUAL CARE Side to side stapled anastomosis OUTCOME Endoscopic recurrence (local and central reading) at 6 months SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients KEYWORDS Crohn, ileocolic resection, recurrence

NCT ID: NCT05135221 Completed - IBD Clinical Trials

Combination Therapy With Two Biologicals

Combi
Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

The efficacy and safety of dual biological therapy.

NCT ID: NCT05086562 Recruiting - Migraine Clinical Trials

Prevalence of Chronic Abdominal Pain in Migraneurs

Start date: September 1, 2021
Phase:
Study type: Observational

To collect data on the prevalence of Chronic Abdominal Pain in Migraneurs in Germany