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IBD clinical trials

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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

NCT ID: NCT04989374 Recruiting - IBD Clinical Trials

Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With IBD

Start date: March 1, 2016
Phase:
Study type: Observational

WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

NCT ID: NCT04827368 Recruiting - Ulcerative Colitis Clinical Trials

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

VOC
Start date: March 22, 2021
Phase:
Study type: Observational

Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.

NCT ID: NCT04790825 Recruiting - Inflammation Clinical Trials

Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

Start date: May 2, 2021
Phase: N/A
Study type: Interventional

Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.

NCT ID: NCT04740541 Recruiting - Crohn Disease Clinical Trials

Threonine Requirement in Adult Males With Crohn's Disease Using IAAO

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

The goal of the current study is to measure the requirement for threonine in patients with CD using the IAAO method and compare the requirement to previously determined threonine requirement estimated in young adults using the IAAO technique. It is hypothesize that the requirement for threonine in patients with CD will be higher than the threonine requirement previously determined in young adults using the IAAO method. Up to 10 clinically stable patients with CD will be recruited from the IBD Clinic at Mt. Sinai Hospital, Toronto, and subsequently followed up at the Clinical Research Center (CRC), The Hospital for Sick Children (SickKids), Toronto, Canada. Before the study begins, the participants will be required to visit the CRC (Room 5500 Hill Wing, The Hospital for Sick Children) for a pre-study assessment of their height, weight, fat mass, fat free mass, resting metabolic rate and medical history. These assessments will take about 3 hours to complete. They will need to have been fasted for 10 hours prior to the pre-study assessment. The pre-study assessment is needed to calculate their dietary requirements for the study, and to assess health status. After signing the consent form, the subjects will complete the screening procedures (height, weight, fasting blood sample and medical history questionnaire, BIA, Skinfold and calorimetry). Each study will consist of a 2-day adaptation period to a prescribed diet in accordance with the energy requirement of the subject and 1-study day. The diet will provide an adequate amount of protein, of 1 g protein/kg/d. The 2-day adaptation period is to allow the body to adapt to an adequate amount of protein as it has been shown that protein kinetics is altered without it. Dietary intakes during this time will be provided in the form of lactose-free milk shakes (Scandishake) with added carbohydrate (SolCarb) and protein (beneprotein) to meet the subjects' requirement. Following the 2 days of adaptation is the study day where threonine intake will be randomly assigned and phenylalanine (Phe) kinetics will be measured with the use of isotopically labelled Phe. On this day, VCO2 will be measured by calorimetry immediately after the 5th meal for a period of 20 minutes. On the study day (3rd day of each 3-day period), the diet will be provided as 8 hourly isocaloric, isonitrogenous meals made up of a flavored liquid formula and protein free cookies developed for use in amino acid kinetic studies. Each meal will represent 1/12th of the subject's total daily requirements. The nitrogen (protein) content of the diet will be provided in the form of a crystalline amino acid mixture based on the amino acid composition of egg protein. - A daily multivitamin supplement will be provided during the study period. - No other food or beverages will be consumed on the adaptation days except water, 1 cup clear tea, or 1 cup clear coffee. - During the 8-hr study day, no other food or drink will be consumed except water. - Urine and breath samples will be collected at baseline and at isotopic steady state. - Breath samples will be collected simultaneously with urine samples. - Five baseline breath samples will be collected 60, 45, 30, 15 min, and just before the tracer protocol begins. - Three baseline urine samples will be collected 60, 30 min, and just before the tracer protocol begins. - Four plateau breath samples will be collected every 15 minutes 2.5 h after the tracer protocol begins. - Three plateau breath samples will be collected every 30 minutes 2.5 h after the tracer protocol begin - Breath samples will be collected with subjects breathing into an Exetainers plastic tube and samples will be stored in pre-evacuated glass tubes at room temperature until analysis. - Urine samples will be collected in Eppendorf tubes and stored at - 20 º C until analyzed for 1-13C phenylalanine enrichment. - The rate of CO2 production (VCO2) will be measured on each testing day using a ventilated hood indirect calorimeter at meal 5 to quantify 13CO2 excretion in breath. Subjects can choose to withdraw from the study at any time and for any reason, based on his/her individual judgment. In particular, if a subject is unable to tolerate the diet, whether it is regards to taste, loose stools or constipated stools, he/she has the right to withdraw at any time during the study.

NCT ID: NCT04733456 Recruiting - IBD Clinical Trials

Brain Activity and Oxygenation Inflammatory Bowel Disease (IBD) Patients

Start date: April 26, 2021
Phase:
Study type: Observational

Symptoms such as fatigue, sleep disturbances, anxiety and depression are common in patients with IBD, but the cause is unknown. Understanding how these behaviors occur in IBD and their role in symptoms may help improve management of IBD. How IBD leads to changes in brain function remains unclear. Inflammation and dysfunction of blood flow may occur in patients with IBD, which may be linked to these symptoms. Patients with IBD also have an alteration or imbalance of gut bacteria which may play a role in the development of the disease, but the exact mechanism remains poorly understood;as a result, there are limited therapeutic options available clinically to address this issue. An approved therapy, anti-TNF α, may be useful in improving brain and gut activity as well as quality of life. The purpose of this research study is to better understand brain and gut activity in the context of IBD to possibly improve treatments for the disease. In patients taking anti-TNFα therapy as prescribed clinically as standard of care, the investigators will measure brain activity using NIRS; gut microbiome using stool analysis and quality of life using various questionnaires.

NCT ID: NCT04457934 Recruiting - Healthy Clinical Trials

Effectiveness of PLENVU in the General Screening Population and Patients With IBD

Start date: September 2020
Phase:
Study type: Observational

Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. The aim is that the final study population will comprise of 50% IBD patients and 50% colorectal cancer screening patients. Before inclusion, all patients have to sign the written informed consent. All participating patients will receive PLENVU, a well-known and approved bowel preparation agent. Bowel preparation is performed following the general recommendations of use. Following the bowel preparation, patients are asked if they have well tolerated the preparation, if they already had a colonoscopy in the past with another bowel preparation agent and if they would prefer PLENVU or another bowel preparation for their next endoscopy examination. Endoscopy is performed in standard way and effectiveness of the bowel preparation is specifically highlighted by the physician on the documentation report. Finally, data is analyzed regarding effectiveness of PLENVU for bowel preparation and patient satisfaction.

NCT ID: NCT03952364 Recruiting - Ulcerative Colitis Clinical Trials

The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

Start date: October 10, 2019
Phase:
Study type: Observational

A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.

NCT ID: NCT03935451 Recruiting - Ulcerative Colitis Clinical Trials

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

EXPAND
Start date: September 1, 2021
Phase: Early Phase 1
Study type: Interventional

Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.

NCT ID: NCT03522623 Recruiting - IBD Clinical Trials

Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study

Start date: November 1, 2017
Phase:
Study type: Observational

inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American study demonstrated the direct costs of caring for children with IBD was double those for adults. Indirect health care costs in children with IBD have not been well-described. The Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new and established IBD clinician-researchers and methodologists from 6 provinces experienced in the use of health administrative data. CanGIEC is evaluating variation in care of children with IBD, and will expand this research stream to assess direct and indirect cost of care. This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12 pediatric IBD centres across Canada. Hypothesis: Direct health costs are dominated by medication expenses (particularly biologics), with resulting variation within and across provinces in costs and out-of-pocket expenses to the families due to coverage disparity. Indirect costs include school and parental absenteeism, and productivity losses. Aims: 1. Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include: a Indirect costs - costs to the patient or family related to having the disease but not to direct health care. b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not covered by the public health or private insurance systems. 2. Determine the sociodemographic and disease characteristics associated with higher costs Methods: Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300). Indirect and OOP disease-related costs will be determined with surveys conducted one year following diagnosis and every 6mo for 2y. These will be conducted querying families on the preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance travelled to appointments, medications expenses incurred, and disability benefits collected. Indirect costs will be calculated using the Human Capital Approach (gross income not earned due to disease).