Celiac Disease (Gluten-Free Diet)

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Celiac Disease (Gluten Free Diet)

General Purpose:

Celiac disease is a disease of the small intestine that results from hypersensitivity to a specific protein known as gluten. Gluten is commonly found in foods made from barley, wheat, and rye, examples of which include bread, pasta, and cereals.

Gluten can also be incorporated as an ingredient in some medications, vitamins, and cosmetics. Individuals who have celiac disease essentially experience an internal allergic reaction within their small intestine each time they consume a food containing gluten, or use a medicine or product in which it is an ingredient.

This immune reaction is damaging to the lining of the small intestine and impairs the body’s ability to absorb nutrients from food.  

No one knows exactly what causes celiac disease, and it can develop at any point in time. Symptoms often vary between individuals which can make it difficult to diagnose. Common symptoms include abdominal pain, bloating, gas, indigestion, constipation, changes in appetite, diarrhea, lactose intolerance, nausea and vomiting, stool irregularities, and unexplained weight loss.

 Additional symptoms may arise over time as a result of nutritional deficiencies that can result from celiac disease. Celiac disease can generally be diagnosed by a special blood test and by examining a sample of intestinal tissue (obtained through a biopsy).

Celiac disease research has made great strides in recent years, with the development and testing of quicker and more accurate diagnostic tests, testing vaccines to prevent the development of celiac disease, and evaluating the effectiveness of current treatments, testing new and potentially useful drugs. Researchers are also working to gain a better understanding of how and why celiac disease develops, and how it responds to various treatments.

What Will Celiac Disease Clinical Trials Be Like?

The types of tests and assessments used in celiac disease clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be used and incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests may be performed to detect exceptionally high levels of certain antibodies (immune system cells that work to eliminate foreign substances). In celiac disease, the body develops antibodies that target gluten, which results in the hypersensitivity that characterizes the condition.
  • Biopsy
  • Endoscopy:  a procedure during which a thin, flexible tube with a tiny light and camera attached to the end is fed down the mouth or nose, through the esophagus, and into the small intestine.
  • Some studies may require that patients swallow a small camera-containing pill that takes thousands of pictures while inside the body, and transmits them to a receiver worn on the patient’s belt. The pill is then excreted from the body in the stool.  
  • Upper GI series: a series of x-rays performed after an individual has fasted for a period of time and then consumed a chalky-tasting liquid that makes the stomach and intestines more visible on x-ray.
  • Dietary interventions, including the elimination of all gluten-containing foods.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Celiac Disease Clinical Trial Protocol:

Specific examples of clinical trials for celiac disease might include the following:

  • A randomized clinical trial in which a type of probiotic bacterial medication (similar to the active cultures found in yogurt) is studied to determine its impact on the symptoms and quality of life measures among women with celiac disease. In such a study, participants would be randomly assigned to receive treatment with either the probiotic medication or a placebo. After a month of therapy, they would be evaluated to determine their degree of symptom improvement, as well as complete a series of questionnaires designed to assess their quality of life.
  • A long-term study to determine if the early feeding patterns of infants – in particular the timing of introduction to gluten-containing foods – are associated with the development of celiac disease. In this study, half of the infants would be randomly assigned to have gluten introduced into their diet per standard recommendations of the American Academy of Pediatrics (i.e., at six months of age), while the remaining half of the infants would continue with a gluten-free diet until the age of 12 months, at which point they could resume an unrestricted diet. Infants would be evaluated every six months until the age of six to assess for the presence of celiac disease. Researchers would then compare the two groups to see if one had more incident cases of celiac disease develop than the other.
  • A study designed to evaluate the effectiveness of a vaccine designed to prevent the development of celiac disease.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the first clinical trial example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of celiac disease (time since onset, age at diagnosis, your specific symptoms)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your current dietary habits (gluten-free, reduced gluten diet, etc.)

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