ClinSearch Tuesday announced it is participating in a global study to help advance celiac disease research. The CeliAction Study (https://www.celiactionstudy.com/) is a clinical research study that is designed to assess whether an investigational drug can improve the damage in the lining of the intestine caused by traces of gluten contaminating a gluten-free diet. The study will also evaluate whether the investigational drug improves any symptoms of celiac disease. ClinSearch has begun enrolling participants at its site in Chattanooga.
Celiac disease is an inherited autoimmune disorder that affects susceptible people of all ages. When people with celiac disease eat certain gluten-containing foods, their immune systems react to the gluten and damages the lining of the small intestine, interfering with their ability to absorb nutrients from the food. Gluten is a plant protein found in foods like wheat, rye and barley. The immune reaction to gluten triggers uncomfortable symptoms including abdominal pain, diarrhea, joint pain, skin rash and mouth sores. Undiagnosed and untreated, celiac disease can lead to the development of other autoimmune disorders, as well as osteoporosis, infertility, neurological conditions and in rare cases, cancer.
About one in every 100 people in the United States has celiac disease. The only available option for people with this disease is to attempt try to follow a strict gluten-free diet.
"While many of those with celiac disease experience some improvement in symptoms after committing to a gluten-free diet, even the slightest exposure to gluten can trigger symptoms and further damage the lining of their small intestines,” said Daniel Leffler, MD, MS, director of Clinical Research at Beth Israel Deaconess Medical Center Celiac Center. “Celiac disease is more than just an upset stomach; the ongoing autoimmune reaction can result in an inability to properly absorb nutrition, which in turn, can lead to long-term serious health issues such as osteoporosis and anemia. Other long-tern complications of the disease, though rare, can include intestinal cancers and lymphoma.”
“There is a real need to develop new treatment options for people with celiac disease,” said Richard Krause, M.D., site principal investigator, ClinSearch. “That’s why we are so excited to let people here in Chattanooga know that if they have been diagnosed with celiac disease and are struggling to manage their celiac disease with only a gluten-free diet, they may qualify to participate in our research program. While participation is not right for everyone, we have a real opportunity here to advance celiac disease research.”
The CeliAction study is looking for diagnosed celiac patients who are at least 18 years old, on a gluten-free diet for at least 11 months and have experienced at least one moderate to severe symptom of celiac disease in the past month. Qualified participants who are randomized will not be intentionally exposed to gluten during the study and must maintain their gluten-free diet throughout the duration of the study.
Qualified participants who are randomized into the 12-week long CeliAction Study will receive access to study-related care from qualified physicians. Qualified participants may also receive compensation for time and travel.
The research study is sponsored by Alvine Pharmaceuticals. For more information, visit www.CeliActionStudy.com or call 1-855-3333-ACT