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Celiac Disease clinical trials

View clinical trials related to Celiac Disease.

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NCT ID: NCT02805816 Completed - Celiac Disease Clinical Trials

Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease

Start date: June 8, 2016
Phase:
Study type: Observational

The investigators will perform prospective observational multicenter study which includes children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study group) and children without suspicion of CD who underwent gastroscopy for other reasons. The investigators will compare sensitivity, specificity and predictive values of several serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD according to histological findings.

NCT ID: NCT02764931 Completed - Clinical trials for Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts. Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected. In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.

NCT ID: NCT02761785 Completed - Clinical trials for Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2

Start date: May 29, 2017
Phase:
Study type: Observational

The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts. Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected. In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.

NCT ID: NCT02754609 Completed - Celiac Disease Clinical Trials

Hookworm Therapy for Coeliac Disease

NainCeD-3
Start date: September 2016
Phase: Phase 1
Study type: Interventional

This trial is a Phase 1b multicentre, multinational, randomized, double-blind with single-blind arm and open label extension phase, placebo controlled, clinical trial evaluating the safety and predictability of an escalating gluten consumption to activate Coeliac Disease (CeD) in (a) a small cohort of people with diet-managed CeD treated with a placebo (n=10), and in (b) cohorts following low (L3-10; n=40) and medium (L3-20; n=10) dose hookworm inocula. The investigators 4 aims for the study are: Aim 1: Undertake a multiple-phase and escalating gluten challenge assessing safety to gluten exposure in hookworm-naïve and hookworm-infected people with CeD. Aim 2: This phase Ib study recognizes that the evidence supporting this novel intervention is rudimentary and addresses amongst others the following questions: (a) The importance of L3 dose on Participant health, and (b) the importance of L3 dose on the safety of escalating gluten challenge and (c) the need for a comparator group should a phase II trial be warranted. Aim 3: Examine the changes in intestinal T cell responses induced by hookworm infection and gluten exposure. Aim 4: Assess the impact of hookworm infection and purified hookworm-derived proteins on gluten peptide-specific immune responses ex vivo.

NCT ID: NCT02711696 Completed - Celiac Disease Clinical Trials

Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]

GluCED
Start date: March 2014
Phase: N/A
Study type: Interventional

The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD): - could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED, Gluten Contamination Elimination Diet); - may depend upon time of exposure to GFD. Investigators studied two cohorts of celiac patients, both on GFD, for at least one year: - cohort A: patients re-biopsied after three months on GCED; - cohort B: patients re-biopsied after a minimum of further two years on standard GFD.

NCT ID: NCT02711397 Completed - Celiac Disease Clinical Trials

Quantification of Gluten Peptides in Feces

DELIAC
Start date: April 2012
Phase:
Study type: Observational

Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serologic tests for CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring. We performed a prospective, non-randomized, multicentre study including 188 CD patients on a GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously.

NCT ID: NCT02690532 Completed - Celiac Disease Clinical Trials

Gut Permeability Assessment in Celiac and Gluten Sensitive Children

Start date: March 2016
Phase:
Study type: Observational

This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water solution), and are hoping to prove its effectiveness in a clinical setting.

NCT ID: NCT02679014 Completed - Celiac Disease Clinical Trials

A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease

Start date: March 6, 2016
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled, two treatment, parallel group study to investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo twice daily with food for 28 days (Days 1 to 28).

NCT ID: NCT02675283 Completed - Coeliac Disease Clinical Trials

Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting

Start date: July 2016
Phase: N/A
Study type: Interventional

This study aims to assess whether it is feasible to use a point of care test to increase the detection of coeliac disease in a pharmacy setting.

NCT ID: NCT02637141 Completed - Celiac Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

Start date: April 13, 2016
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.