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Celiac Disease in Children clinical trials

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NCT ID: NCT06364735 Not yet recruiting - Clinical trials for Celiac Disease in Children

Entities and Variables Related to Catch-up Growth

Start date: May 1, 2024
Phase:
Study type: Observational

A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.

NCT ID: NCT06356220 Not yet recruiting - Clinical trials for Celiac Disease in Children

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

GF-NOURISH
Start date: July 2024
Phase: N/A
Study type: Interventional

We propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. We hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

NCT ID: NCT06206616 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Liver Steatosis in Pediatric CD Patients

Start date: June 1, 2024
Phase:
Study type: Observational

Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci/asymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD. More recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD). In adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data. Several factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota. The objectives of this study are: 1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD. 2. define the possible role of the intestinal permeability alteration and/or the intestinal mucosa damage and/or the proinflammatory status in the development of NAFLD in children affected by CD.

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: 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.

NCT ID: NCT04440501 Not yet recruiting - Clinical trials for Celiac Disease in Children

Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease

VIRTUE
Start date: September 28, 2022
Phase: N/A
Study type: Interventional

1. Specific Aim (1) is to assess both the immediate and longer term impact of VIRTUE on the patient's GFD knowledge compared to standard of care (SOC) dietary education. 2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL, symptomatology, and Celiac biomarkers (tissue transglutaminase antibodies, deamidated gliadin peptide IgA, deamidated gliadin peptide IgG, and total serum IgA).

NCT ID: NCT04019223 Not yet recruiting - Clinical trials for Celiac Disease in Children

Anti-Tissue Transglutaminase IgA Antibodies

Start date: October 1, 2019
Phase:
Study type: Observational

Celiac disease is the most common genetically related food intolerance, worldwide. It is an immune mediated intolerance to gluten (from wheat, barley, or rye) in genetically susceptible individuals .The disease primarily affects the small intestine, where it progressively leads to flattening of the small intestinal mucosa .

NCT ID: NCT03244254 Not yet recruiting - Clinical trials for Celiac Disease in Children

Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients

Start date: November 2017
Phase: N/A
Study type: Observational

A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.