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Current Medical Trials on Celiac Disease

Woman Doctor is Writing a Card of a Patient

As of April 2011, there were more than a dozen active clinical trials studying celiac disease listed by the NIH website ClinicalTrials.gov. These are currently recruiting patients or planning on recruiting patients. More than three dozen completed trials are also listed, but their results are not yet published. Hospitals and medical centers all over the world are trying to learn more about the clinical course of celiac disease and how to better diagnose and treat it.

The following are active trials that are recruiting or going to recruit or invite participants. Many are taking place outside of the United States, but there are active trials in the United States (indicated by**). If you think you might be interested in one of the studies, you should look at the website and find the contact information.

STUDIES ON DIAGNOSIS OF CELIAC DISEASE

Intestinal PermeabilityTest   
This study will use patients with celiac disease as well as healthy volunteers to evaluate new ways to test intestinal permeability. (The Netherlands)

Stain for T cells to Diagnose CD
HLA-DQ2 patients with or without CD will have small bowel biopsies and specific T cells stained before and after a gluten challenge for 3 days. (Norway)

**Other Diagnostic Blood Tests
Patients with CD on a gluten-free diet with negative antibody tests will be given a low-gluten or high-gluten diet for four weeks, and blood tests and biopsies will be performed to try and find tests that show CD earlier. (Boston, Massachusetts)

TREATMENT

Probiotic Bifidobacterium Infantis
Patients with celiac disease and positive antibody tests will be assigned as controls or to take the probiotic bacteria for three weeks, with a gluten challenge. Intestinal permeability will be evaluated at the beginning and end of the trial. Also T cells will be checked for chemical activity and intestinal biopsies will be done. (Argentina)

ALV003 treatment
This is a combination of two enzymes to digest gluten peptides. Phase 2a double-blind, placebo-controlled trial to determine safety and effectiveness of 6 weeks treatment with various doses. Intestinal biopsy at end plus blood tests. Must have biopsy proven CD. (Finland)

**Enzyme Treatment (STAN 1)
Patients with celiac disease ages 12 to 65 years will be given placebo, enzymes or enzymes and gluten for 12 weeks. Evaluated by autoantibodies, symptoms and intestinal biopsy. (Stanford University and Norway)

Treatment of CD with Gluten-Free Diet
Asymptomatic patients with positive endomysial antibodies treated with gluten-free diet or nothing and assessed over a year. (Finland)

GENERAL

**Neurologic Problems Associated With CD & Ataxia
Patients with CD and ataxia will be compared with patients with just ataxia, patients with just CD, and normal controls. A number of blood tests will be evaluated to see if they can be used to detect neurologic problems. (NIH, Maryland)

**Infant Nutrition and Risk of CD
Infants up to six months old who are positive for HLA-DQ2 or DQ8 who have first degree relatives with CD. They will be on a gluten-free or gluten-containing diet until a year of age, and assessed to see if they have developed CD. (University of Maryland.)

**Celiac Disease Quality of Life
Based on blood samples positive for celiac antibodies, patients 60 years or older. Patients with positive samples will be invited into the study and if they do have celiac disease, they will be given including instruction on gluten-free diet and followed for one year. Mayo Clinic. (Rochester, Minnesota)

**Database
Patients with celiac disease at the University of Chicago Medical Center. Observational over time. Children and adults. (Chicago)

Impact of Diagnosis on Quality of Life
Five-year study of members of the Finish Celiac Society with biopsy-proven CD. (Finland)

Changes in Saliva Before and After the Guten Free Diet
Israeli children with CD, looking at their saliva, teeth, and mouth ulcers. (Israel)

Immune Reaction to Hepatitis B Vaccine
An alternate vaccine will be given to children with CD who did not react to the standard vaccine. (Israel)

Oats, Not Contaminated With Gluten
Study of children with CD given gluten-free oats to see if they react to the protein in oats. (Italy)

**Patients With Irritable Bowel Syndrome Who Are Also HLA-DQ2 Positive
They will be given a gluten-free or gluten-rich diet and tested for markers of CD. (Mayo Clinic)

While many of these studies are not in the United States, it is interesting to see what is being studied. The results of some of these trials may have an impact on the way celiac disease is diagnosed and treated.

New trials may be listed at any time.  If you are seeing a specialist or are being treated at a large medical center you can also ask if there are any studies planned in the future.

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