A Guide to Celiac Disease and Clinical Trials


Celiac disease, also referred to as celiac sprue or gluten-sensitive enteropathy, is an autoimmune disorder characterized by an adverse reaction to gluten. Gluten is a protein found in wheat, barley, rye, and other grains. 

When individuals with celiac disease consume gluten, their immune systems respond by attacking the lining of the small intestine, causing inflammation and damage to the villi – tiny, finger-like projections responsible for absorbing the nutrients from ingested food.

Although we don’t understand the precise cause of celiac disease, it is believed to be triggered by a combination of genetic, environmental, and immune system factors. 

What Causes Celiac Disease?

Researchers have been unable to determine exactly what causes celiac disease, although we do know that patients must inherit specific genes (HLA-DQ2 and HLA-DQ8)  to develop it. Still, not everyone with these “celiac genes” will get the disease.

People who are predisposed to celiac disease due to their genetics may also have a higher risk due to: 

  • High gluten exposure
  • Having another autoimmune disease
  • Living at a higher latitude
  • Exposure to organic pollutants
  • Catching certain viruses 

How Common Is Celiac Disease? 

The Celiac Disease Foundation estimates that the disease affects 1 in every 100 people worldwide, but only about 30% of cases are properly diagnosed. Currently, roughly 2 million people in the United States are diagnosed with celiac disease. 

Celiac disease tends to be more prevalent in women and children, although researchers are not exactly sure why. Some theorize that women are more likely to seek medical help for their symptoms than men, but it could also be that men and women tend to manifest different symptom profiles. 

Symptoms of Celiac Disease

Celiac disease can generate a wide range of symptoms, all of which can vary significantly between individuals. Some people may experience classic digestive symptoms, while others may have symptoms unrelated to the digestive system. 
Some of the most common symptoms associated with celiac disease include:

Some of the most common symptoms associated with celiac disease include:

  • Abdominal pain and cramping
  • Bloating and gas
  • Diarrhea or constipation
  • Nausea and vomiting
  • Pale, foul-smelling, or fatty stools
  • Fatigue and weakness
  • Anemia (low red blood cell count) 
  • Unexplained weight loss or failure to gain weight (especially in children)
  • Irritability and mood changes
  • Depression or anxiety
  • Joint pain and muscle cramps
  • Bone pain or osteoporosis 
  • Skin rashes
  • Mouth sores
  • Missed menstrual periods or fertility issues

Of course, many of these symptoms can be caused by other conditions, and the presence of one or more of these symptoms does not necessarily indicate celiac disease. Patients will need to undergo a medical evaluation and proper diagnostic testing to confirm their diagnosis of celiac disease.

If you suspect you or someone you know might have celiac disease, consult a healthcare professional for proper evaluation.

Match With Celiac Disease Clinical Trials

Have you been diagnosed with celiac disease? If so, you may qualify for a clinical trial near you. At Tandem Clinical Research, we’ll help you match with the following:

  • Scientific clinical studies
  • Research clinics in your area 
  • The latest celiac disease treatments

How Celiac Disease Is Diagnosed 

(1) Medical Evaluation

The first step in diagnosing celiac disease is having a healthcare provider conduct a thorough medical history assessment and physical examination. They will ask about the patient’s symptoms, family history, and any relevant medical conditions.

(2) Blood Testing

Typically, the healthcare provider will call for blood tests to screen for celiac disease. The primary blood test is the tissue transglutaminase antibody (tTG-IgA) test. If the test finds elevated levels of these antibodies, it may indicate an adverse immune response to gluten. 

In some cases, these tests may also look for specific antibodies associated with celiac disease, such as anti-endomysial antibodies (EMA) or anti-deamidated gliadin peptide (DGP) antibodies. Blood tests can also evaluate nutritional deficiencies, such as iron, vitamin D, and vitamin B12 levels.

(3) Intestinal Biopsy 

If the blood tests indicate a high likelihood of celiac disease, the healthcare provider may recommend an intestinal biopsy to confirm the diagnosis. This involves the removal of a small tissue sample from the lining of the small intestine, typically through an endoscopy. The tissue sample is then examined under a microscope to look for characteristic damage to the villi, which is a hallmark of celiac disease.

Note: individuals should not start a gluten-free diet before undergoing testing, as it can interfere with accurate results. If someone has already begun a gluten-free diet, they may need to undergo a gluten challenge under medical supervision to obtain accurate diagnostic results.

Potential Treatments for Celiac Disease

There is currently no set treatment or “cure” for celiac disease. However, there are steps individuals can take to minimize their symptoms and help prevent further complications. 

Some common recommendations from your healthcare provider may include:

People with celiac disease will likely need to start sticking to a gluten-free diet, which involves avoiding foods that contain wheat, barley, rye, and their derivatives. This usually includes steering clear of:

  • Bread
  • Pasta
  • Cereals,
  • Baked goods
  • Beer
  • Many processed foods. 

The good news is that there are now many gluten-free alternatives available, including gluten-free grains (e.g., rice, quinoa), flours, and gluten-free versions of common foods.

If you have been diagnosed with celiac disease, you might want to work with a registered dietitian who specializes in the condition. They will provide guidance on maintaining a balanced diet, understanding food labels, meal planning, and navigating social situations as someone with dietary restrictions.

Currently, there are no medications to treat or cure celiac disease. However, some medications can help manage specific symptoms or complications associated with the condition, such as medications for acid reflux, osteoporosis, or dermatitis herpetiformis.

In some cases, the malabsorption of nutrients caused by celiac disease may cause deficiencies in patients. These individuals will likely need to take supplements such as iron, calcium, vitamin D, or vitamin B12.

Celiac Disease Clinical Trials

Tandem Clinical Research matches individuals with reputable clinical trials conducted by pharmaceutical, biotech, and medical device companies. If you live near New York City, New Orleans, or Orlando, reach out to find an appropriate trial. 

Although celiac disease cannot currently be cured, scientists and doctors are continuously researching potential new treatments. The more we learn about the disease and its triggers, the better we can become at treating symptoms and preventing complications. 

If you have celiac disease, learn more about contributing to ongoing research. 

How to Support Others With Celiac Disease

Supporting friends or family members with celiac disease involves understanding the challenges they face and offering practical and emotional support. Here are some ways you can lend a helping hand to those with celiac disease.

Educate Yourself on the Condition 

Begin by taking the time to learn about the disease, its symptoms, and gluten-free diets. More specifically, educate yourself on cross-contamination and hidden sources of gluten that could pose threats to your loved one. 

Work to Accommodate Their Dietary Needs 

If you’re planning a meal or social event, try to take your loved one’s dietary restrictions into account. Offer gluten-free options and ask what you can do to prevent cross-contamination issues. 

Offer Emotional Support 

Living with any chronic condition is emotionally taxing. Sometimes, the best thing you can do for your loved one is simply to listen to their frustrations and other feelings. Encourage open communication and let them know they can talk to you about their experience with celiac disease.

Match With Celiac Disease Clinical Trials

If you have been diagnosed with celiac disease, you could be a candidate for ongoing clinical studies. These trials allow researchers to obtain critical information about this disease, which can influence future treatment options. 

Scientists and doctors are studying many aspects of celiac disease and gluten intolerance. This includes the assessment of:

  • new treatment possibilities 
  • how genetics and environmental factors increase the risk of celiac disease 
  • how the disease develops and progresses

At Tandem Clinical Research, we often conduct celiac disease clinical trials. Get matched with one near you today.