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Celiac Disease clinical trials

View clinical trials related to Celiac Disease.

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NCT ID: NCT02242123 Completed - Celiac Disease Clinical Trials

Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

Start date: January 2012
Phase:
Study type: Observational

Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically predisposed populations. Patients affected by the disease may be asymptomatic or manifest classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss after gluten ingestion (and related derivatives found in other grains). Diagnosis and screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG) and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in identifying susceptible individuals. CD diagnosis is still anchored to the criteria established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition in 1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia and increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten, and (b) a full clinical remission after elimination of gluten from the diet. As a consequence, patients with minimal or no intestinal histology lesions pose a considerable problem, as serum anti-tTG and EmA are known to be often negative, or weakly positive, in patients with CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG antibody in the culture medium of intestinal biopsy specimens from patients with suspected CD and evaluated the relationship between antibody production and severity of intestinal mucosal damage, and demonstrated that anti-tTG assay of the culture medium of biopsy specimens can improve the accuracy of CD diagnosis in patients negative for serum antibodies. The same investigators, in 2011, evaluated the diagnostic accuracy of EmA assay in the culture medium of intestinal biopsies for CD diagnosis and demonstrated that EmA assay in the culture medium had a higher sensitivity and specificity than serum EmA and anti-tTG assay. The present study is performed to investigate the clinical usefulness of the in vitro production of EmA in CD diagnosis in a large number of consecutive adult patients with suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG.

NCT ID: NCT02220166 Completed - Celiac Disease Clinical Trials

Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Start date: November 2010
Phase: Phase 2
Study type: Interventional

Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated. The aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.

NCT ID: NCT02203201 Completed - Clinical trials for Not-celiac Gluten Sensitivity

Diagnostic Significance of Positive EmA Antibodies in the Duodenal Culture Medium of Not-Celiac Wheat Sensitivity (NCWS)

NCWS
Start date: January 1, 2014
Phase:
Study type: Observational

The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e. celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides celiac disease and wheat allergy, there are cases of gluten reactions in which neither autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion, and an elimination diet and an "open challenge" (i.e., the monitored reintroduction of gluten-containing foods) are most often used to evaluate whether health improves or worsen with the elimination or reintroduction of gluten in the diet, respectively. In some circumstances, it is very difficult to distinguish between NCWS and celiac disease. The presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the diagnosis. However, it is well known that the frequency of a positive serology is dependent by the severity of the intestinal damage. Consequently, patients with less severe histology damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that EmAs are produced by the intestinal lymphocytes and previous data from our group showed that EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the culture medium of the duodenal biopsies at the time of the first evaluation, and the adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS diagnosis based on double-blinded placebo-controlled (DBPC) challenge.

NCT ID: NCT02202681 Enrolling by invitation - Healthy Clinical Trials

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Start date: September 16, 2013
Phase: N/A
Study type: Interventional

The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum. A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.

NCT ID: NCT02190513 Completed - Celiac Disease Clinical Trials

Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease

Start date: February 2011
Phase: N/A
Study type: Observational

Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the gastrointestinal tract with specific clinico-pathological characteristics. In recent years, in the literature, several children who underwent upper gastrointestinal endoscopy for suspected CD, which was confirmed histologically, were also found to have coexistent EE. There are reports of coexistent CD and EE. We would like to see the prevalence of EE in children with CD and the prevalence of CD in children with EE in our population, and to do so would like to review medical records. Our objectives are to determine if children with celiac disease have a high prevalence of eosinophilic esophagitis.and to determine if children with eosinophilic esophagitis have increased risk of developing celiac disease.

NCT ID: NCT02126033 Not yet recruiting - Celiac Disease Clinical Trials

Telomeres Parameters in Celiac Disease

Start date: n/a
Phase: N/A
Study type: Interventional

Celiac disease is an autoimmune process that causes destructive changes in the epithel of the small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is to examine telomere length and other parameters of genetic instability from peripheral blood lymphocytes of patients with celiac disease compared with healthy controls.

NCT ID: NCT02072590 Completed - Celiac Disease Clinical Trials

Improved Diagnostics of Celiac Disease in Children

Start date: August 2011
Phase:
Study type: Observational

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

NCT ID: NCT02061306 Recruiting - Celiac Disease Clinical Trials

Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

CDGEMM
Start date: March 2014
Phase:
Study type: Observational

Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.

NCT ID: NCT02036944 Terminated - Celiac Disease Clinical Trials

Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting

Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine if patients with unexplained iron deficiency have underlying diseases processes such as celiac disease. It is hypothesized that selectively screening patients with unexplained iron deficiency will reveal previously undiagnosed etiologies, including celiac disease and other causes of iron malabsorption along with various sources of occult GI blood loss.

NCT ID: NCT01990885 Completed - Celiac Disease Clinical Trials

Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.

Start date: December 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single oral administration and in repeated oral administration to well-controlled celiac patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.