Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases...
Inflammatory Bowel DiseaseClinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital
Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC...
Colorectal CancerPrecancerous Lesion1 moreColorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel DiseaseUlcerative Colitis1 moreThis study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments. Patients between the ages of 0 and 75 years of age with Crohn s disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy. Participants will receive medical treatment according to the best generally accepted measures for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure. In addition, participants may undergo the following procedures: Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of blood per kilogram (2.2. pounds) of body weight will be obtained from children within the same time period, with no more than 3 ml/kg taken at any one time. Leukapheresis - This procedure is done to collect large quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is circulated through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm. Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with intestinal biopsy in patients who require this procedure as part of their standard medical care. Patients are given a sedative to reduce anxiety, but are conscious during the procedure. A flexible tube is inserted into the rectum and large intestine, allowing the physician to see the intestinal mucosa. At various places, small pieces of tissue are plucked out.
Digital Versus Telephone Symptom Assessment and Triage in Primary Care
InfectionsInjuries3 moreA 'digital-first' approach is currently under implementation in several Swedish regions. The principles behind implementing an online service as an access way to primary care are based on an expectation that it can make access easier, direct people to appropriate levels of care, and increase both availability of heath care and cost efficiency. However, a recent Swedish report concluded that digital triage in primary care has not been investigated in a clinical real-world setting, including real patients, meaning that the benefits and risks for patients as well as on a system level remain unclear. The aim of this trial is to study the feasibility of a larger trial that will compare digital triage and traditional telephone triage on adherence to triaged health care level, in a randomized controlled study (feasibility study, RCT). The study will recruit a total of 120 patients, of which half will be randomized to telephone triage and half to digital triage.
Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
Inflammatory Bowel DiseasesUlcerative ColitisThis study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.
IBD Strong Peer2Peer for Self-Management of Psychological Distress
Inflammatory Bowel DiseasesUlcerative Colitis1 morePsychological distress (PD) as a result of inflammatory bowel disease (IBD) is prevalent and associated with worse disease-related outcomes. IBD-associated psychological distress (IBD-PD) is particularly common at initial diagnosis, during disease flares, before surgery, and during transitions of care. Access to evidence-based, gold-standard psychological interventions and emotional support for IBD-PD has been identified as a major care gap by persons living with IBD. The COVID-19 pandemic has further exacerbated the burden of PD for persons living with chronic diseases like IBD, predisposing at-risk individuals to even greater mental struggles. Studies have shown a minority of patients are asked about IBD-PD in routine clinical care and that even if asked, access to mental health care is extremely limited. iPeer2Peer is an evidence-based, peer-led, virtually administered intervention for IBD-PD in the pediatric population that has demonstrated feasibility, acceptability and early effectiveness. Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD. This program, IBD Strong Peer, will be studied through a randomized, wait list-controlled hybrid implementation-effectiveness trial in Nova Scotia. This study will provide implementation data needed to improve and adapt the intervention and implementation strategy to meet local needs, as well as provide early effectiveness data. This data will inform the design and statistical power needed for future larger, multicenter randomized control trials. IBD Strong Peer has significant potential to improve access to evidence-informed interventions for IBD-PD.
Hormonal Influences on Inflammatory Bowel Diseases
Inflammatory Bowel DiseasesContraception1 moreOf the 1.8 million U.S. women with inflammatory bowel diseases (IBD), over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. Long acting reversible contraception, including the etonogestrel (ENG) contraceptive implant and levonorgestrel (LNG) intrauterine device (IUD), are the most effective contraceptive options with excellent safety profiles and are highly desired if access barriers are removed, thus ideal for study in this population. In our previous cross-sectional study, 47% of the levonorgestrel (LNG) IUD users reported improvement in their cyclical IBD symptoms, but ENG implant use was uncommon and prospective data on the effect of either the IUD or implant on symptoms remain lacking. In order to design a future comparative effectiveness trial on the effect of the ENG implant and LNG IUD on menstrual-related IBD symptoms, the investigators propose this pilot randomized controlled trial with a participant-preference arm to define a feasible study design and recruitment plan, determine metrics to differentiate between non-menstrual and menstrual-related IBD symptoms, and explore the potential role of use of inflammatory markers in future trials. The investigators will recruit participants from the University of Utah IBD Center and clinics and through social media ads. Total study commitment will be ~8 months which includes two spontaneous menstrual cycles prior to contraceptive initiation and then six months of follow-up. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers commonly used for IBD management. Our aims include: (1) To determine acceptability of randomization to the ENG contraceptive implant or 52mg-LNG IUD and in those who decline, acceptability of participation in a participant-preference arm, (2) To obtain estimates of means and standard deviations in established IBD symptom scales (Harvey Bradshaw and partial Mayo) and IBD quality of life measures across the phases of two menstrual cycles and then for 6 months after contraceptive method initiation, and (3) To obtain preliminary estimates of inflammatory marker variation across menstrual phases and pre- and post- contraceptive initiation. This pilot will inform a future trial design and this line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.
Dried Chicory Root in IBD
Inflammatory Bowel DiseasesDietary ExposureThe goal of this clinical pilot trial is to test the use of dried chicory root in patients with IBD. The main questions it aims to answer are: what the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber). Researchers will compare the above mentioned outcomes before and after the intervention.
Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
Small Bowel DiseaseIn this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.
Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
Inflammatory Bowel DiseasesThis is a clinical trial of nabilone for patients with Inflammatory Bowel Disease (IBD) who are undergoing IBD-related surgery (Any abdominal surgery lasting for more than one hour). This study would include a total of 80 patients undergoing general surgery who will have Intravenous Patient Controlled Analgesia (IVPCA) after surgery. It is the intention to randomize these patients postoperatively into 2 groups of 40 patients: Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and nabilone as per protocol. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo as per protocol. The goal is two-fold. One is to demonstrate that patients will benefit from post-operative nabilone administration to achieve/maintain the opioid-sparing and pain modulation effects. Second is to demonstrate patients will benefit from the anti-inflammatory and immunomodulatory effects of nabilone to alleviate IBD symptoms and enhance recovery.