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Celiac Disease clinical trials

View clinical trials related to Celiac Disease.

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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: NCT06324604 Not yet recruiting - Healthy Volunteers Clinical Trials

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Start date: June 2024
Phase: Phase 1
Study type: Interventional

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

NCT ID: NCT06310291 Not yet recruiting - Celiac Disease Clinical Trials

VTP-1000 in Adults With Celiac Disease

Start date: April 2024
Phase: Early Phase 1
Study type: Interventional

GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.

NCT ID: NCT06300164 Not yet recruiting - Celiac Disease Clinical Trials

The Effect of Unripe Carob Fruit in Celiac Patients

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction.

NCT ID: NCT06283264 Not yet recruiting - Celiac Disease Clinical Trials

Assessment of Coeliac Disease in Patients With Type 2 Diabetes

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

This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status

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: NCT06184906 Not yet recruiting - Weaning Failure Clinical Trials

Preventing Celiac Disease by Weaning With Mediterranean Diet

PEMED
Start date: January 15, 2024
Phase: Phase 3
Study type: Interventional

Background: The introduction of solid foods in alignment with the Mediterranean Diet (MD) post-exclusive milk feeding has been demonstrated to cultivate a lasting affinity for healthy eating during infancy and childhood. Despite this, access to healthy diets remains a challenge for numerous children, particularly in underserved areas. The clinical trial under discussion is set in Scampia, a municipality in Naples, Italy, known for its dense population and socio-economic challenges. This trial, utilizing the Family Pediatrician (FP) system, aims to promote MD nutrition among children in Scampia to potentially prevent or reduce chronic childhood diseases. Study Design: In this pragmatic trial, FPs are utilized as the unit for randomization to administer the intervention. The intervention group will be introduced to an intensified MD-based diet from weaning, incorporating adult-type MD foods, while the control group will follow standard regional dietary guidelines. Dietary adherence and health outcomes are to be periodically monitored, and genetic and microbiome analyses will be conducted using collected saliva and stool samples. Incorporating a Bayesian group sequential design, this trial is structured to conduct interim analyses for efficacy, aligning with local healthcare systems for optimal resource allocation. Conclusion: The study is poised to be methodologically innovative and socially impactful, utilizing existing healthcare frameworks to enhance childhood nutrition in challenging environments. Outcomes from this trial are expected to provide valuable insights into the effects of MD-based nutrition on child health and potentially serve as a model for promoting healthier diets in urban suburbs globally.

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: 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.