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Celiac Disease clinical trials

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NCT ID: NCT06179121 Enrolling by invitation - Clinical trials for Celiac Disease in Children

"Adding DNA-test for Screening of HLA-DQ2 and DQ8 to Improve Early Diagnosis of Celiac Disease"

GLUTEN-GEN
Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Celiac Disease (CD) is an immune-mediated systemic disorder elicited by the ingestion of gluten containing cereals from the normal diet, among others wheat, rye and barley. The disease is characterized by a variable combination of gluten-dependent clinical manifestations, CD specific antibodies, human leukocyte antigen (HLA)-DQ2 or HLA-DQ8 haplotypes and chronic inflammation of the small bowel.CD is one of the most common lifelong food- related disorders; it has a frequency of 1% in the general population: this corresponds to 170.000 persons in the Netherlands, and of them at least 30.000 children. However, CD is frequently unrecognized, partially because of its variable clinical presentations and symptoms. That timely diagnosis and treatment of CD could be achieved by active case-finding, show the preliminary results of the ongoing ZonMw sponsored project GLUTENSCREEN (531002001; www.glutenscreen.nl). Currently, HLA-typing is not a part of GLUTENSCREEN because current technique presents important drawbacks in settings without the availability of a laboratory. We here propose to develop a novel test for DNA isolation for HLA typing extracted from the dried blood spots obtained from the POCT at the Preventive YHCCs for early detection of CD. Repeated testing for CD could be omitted in children tested HLA-DQ2/8 negative, this reflects to 60% of the targeted population. To embed this technique in the case finding setting at the YHCCs, the test will be offered to a significant part of the general Dutch population between 0-4 years old, since more than 95% of the general population visit the YHCC. Primary Objective: To validate the HLA-DQ typing in blood taken by a fingerprick; to make it feasible in the regular Preventive YHCCs organization. Study population: Phase 1: From 50 children attending the LUMC dept. of Pediatrics because of suspected CD in whom traditional HLA-typing is part of their standard of care or from children with diagnosed CD in whom their HLA typing is already known. Phase 2: All parents of symptomatic children, 1-4 years of age, who visit the Preventive YHCC in the region of Kennemerland, will be asked to participate in this study.

NCT ID: NCT06178107 Recruiting - Celiac Disease Clinical Trials

Efficacy of Cholesterol-lowering L. Plantarum on Cardiometabolic Health Biomarkers in Coeliac Disease Patients

ProCoChoL
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies suggest the existence of other factors capable of contributing to the onset of the disease, such as intestinal dysbiosis. We have also seen how each of us has a specific microbiota, defined as an individual human enterotype, which depends on our background and can be modified by the diet. Recently, much interest has been directed to a strain of lactobacilli, called Lactobacillus plantarum (LP-LDL®) capable of reducing cholesterol and preventing the reabsorption of bile salts in the liver. The efficacy of this bacterial strain has been confirmed in 3 different human studies demonstrating the efficacy of LP-LDL® in patients with high baseline cholesterol (TC> 6mmol / L). This is a food supplement that has been commercially available in multiple formulations in Europe for over 3 years. LP-LDP is a probiotic strain, safe to use, selected for its high bile salt hydrolase in vitro, and in vivo cholesterol reduction activity. The intake of 2 Å~ 109 CFU encapsulated LP-LDL twice daily, significantly reduced LDL-C (13.9%), total cholesterol (TC) (37.6%), TG (53.9%), and significantly increased HDL-C (14.7%; in subjects >60 years of age; 6-12 weeks) in normal to mildly hypercholesterolaemic subjects. In a recent double-blind placebo-controlled human study published by the Journal of Functional Foods (2022) and carried out by the University of Roehampton (UK), LPLDL showcased statistically significant reductions in multiple cardiovascular risk biomarkers, including total cholesterol, LDL cholesterol, non-HDL cholesterol and apoB. No adverse effects were noted throughout the study. We are here proposing a pilot human intervention study to evaluate the effectiveness of the LP-LDL® probiotic in reducing cardiovascular risk factors inclusive of cholesterol in the blood in people with coeliac disease.

NCT ID: NCT06164548 Not yet recruiting - Celiac Disease Clinical Trials

Celiac Disease Among Egyptian Children With Unexplained Short Stature

Start date: January 15, 2024
Phase:
Study type: Observational

Detect the prevalence of celiac disease in children with unexplained short stature attended at Assiut University Children Hospital.

NCT ID: NCT06152289 Recruiting - Crohn Disease Clinical Trials

Development of New Diagnostic Tools in Capsule Endoscopy

NOCE
Start date: February 10, 2023
Phase:
Study type: Observational

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

NCT ID: NCT06151782 Recruiting - Celiac Disease Clinical Trials

Immunosafe-CeD: Are Partially Hydrolysed Gluten Hamrful to Celiac Disease Patients?

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The study will compare the immune response in CeD patients to wheat and barley gluten at high doses (1 gram), and also investigate the reponses to low dose barley gluten and also hydrolyzed, malted barley. This will be done by four one-day challenges with intervals around four weeks.

NCT ID: NCT06149507 Not yet recruiting - Clinical trials for Celiac Disease in Children

Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease

Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

Celiac disease (CD) is a chronic autoimmune enteropathy. It results from genetic predisposition and exposure to gluten-containing food. Individuals carrying human leucocytes antigen (HLA) markers DQ2 or DQ8 are genetically predisposed. Gluten is a protein found in wheat, rye, and barley; the main ingredients of bread, pasta, and pastries. Gluten works as a triggering factor for CD, but the interaction between genetic and environmental factors is still not fully understood. Celiac disease can alter the absorption of drugs. Due to its vast surface area compared with the stomach, most drug absorption occurs in the small intestine and in celiac disease; the surface area available for absorption is substantially reduced due to villous atrophy. Patients with celiac disease develop a variety of gastric disorders requiring oral medications, but the impact of damage to intestinal villi and other celiac disease squeal on drug absorption remains poorly understood. A review of the pertinent literature (English-language articles on research in adults published during the period 1970-August 2012) identified several reports of altered drug absorption mechanisms in patients with celiac disease, including accelerated or delayed gastric emptying, increased permeability of jejunal mucosa, changes in intraluminal pH, decreased intestinal surface area, and reduced intestinal cytochrome P-450 enzymes. A small number of published studies suggest that celiac disease may be associated with altered drug absorption, resulting in higher serum concentrations of propranolol, lower peak concentrations of acetaminophen and practolol, higher dosing requirements with levothyroxine, impaired or delayed absorption of certain antibiotics, and other pharmacokinetic effects with a potential impact on medication efficacy and toxicity. However, these studies involved very small patient samples and were poorly controlled, with some yielding contradictory results. More and larger pharmacokinetic studies in patients with celiac disease-especially studies of drugs that are dosed empirically or are not amenable to dosage adjustment according to vital signs or laboratory values-are needed.

NCT ID: NCT06072287 Recruiting - Obesity Clinical Trials

The Living With a Long-Term Condition Study

LTC
Start date: June 28, 2023
Phase:
Study type: Observational

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is. The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

NCT ID: NCT06059716 Not yet recruiting - Celiac Disease Clinical Trials

Gluten Technology and Education for Celiac Health

GLUTECH
Start date: November 2023
Phase: N/A
Study type: Interventional

The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

NCT ID: NCT06038344 Active, not recruiting - Clinical trials for Adherence, Treatment

Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease

Start date: June 22, 2021
Phase: N/A
Study type: Interventional

Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of sugar and fat. Current Canadian nutrition guideline does not address these nutritional limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD in newly diagnosed children and youth with celiac disease in the clinical setting. The investigators will compare dietary counselling using the GFFG versus the standard of care in children newly diagnosed with CD and their parents to see if participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) improved over six months.

NCT ID: NCT06007898 Not yet recruiting - Celiac Disease Clinical Trials

Supporting Children and Young People to Live Well With Coeliac Disease

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

Managing a strict gluten-free diet is crucial for children and young people with coeliac disease. However, this can have adverse effects on psychological well-being and quality of life. Despite appeals from families, clinicians, and researchers, psychological support is not routinely provided to these families. This project aims to adapt existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. The process involves collaboration with families and clinicians to modify these resources. Subsequently, a feasibility randomised controlled trial will be conducted to assess the viability and acceptability of these resources. In the trial, 50 families will complete well-being and quality of life questionnaires, along with assessments of their child's gluten-free dietary management. Families will be divided into groups receiving the psychological resources either immediately or after a two-month delay. Follow-up questionnaires will be administered at one and two months for all families, regardless of intervention access. Feedback on the resources and research participation will be gathered. The expectation is that these self-help psychological resources for parents will enhance gluten-free diet management, quality of life for coeliac children and young people, and well-being for parents.