Active clinical trials for "Celiac Disease"

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.

Background: Celiac disease is an immune-mediated reaction to gluten, presenting with diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison sample). It is hypothesized that a gluten free diet in people with schizophrenia who have Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life. Objectives: The aim of this proposed pilot study is to establish the feasibility of a initiating and maintaining a Gluten-free diet in these two groups. For this study The investigators will identify 8 individuals who have positive assays to tTG antibodies and confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The investigators plan to consent at least 2 subjects from each group and ask them to participate in a two-week open label treatment of a gluten free diet. The groups are; Celiac disease (positive tTG antibody); and Positive assay on Antigliadin antibodies

A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.

Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.

The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy

This study is to characterize the safety and tolerability of an investigational drug called TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease. The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and urine, and study subject health will also be monitored by vital signs such as blood pressure, electrocardiogram (ECG), and physical examination.

Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes expressing T-cell receptor (TCR) gamma/delta+. Aim: To demonstrate the existence of CGS in these patients despite having negative celiac serology. Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6 months in patients with LE on a GFD. Inclusion criteria: >18 years, initial presentation with GI symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological response to GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin) (identical powder sachets mixed with meals). Clinical symptoms were analysed using visual analogue scales. Quality of life (GIQLI), adherence to diet, serology, and histological changes including gamma/delta+ IEL and tTG deposits were evaluated.

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).

The study will identify a cohort of infants at risk for celiac disease that can be followed on a long term basis for investigating the natural history the celiac disease based on the pattern of early nutrition. The study will investigate possible early feeding patterns including the timing of introduction to gluten that may protect at least in part from CD development in at risk infants.

This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.