By Van Waffle
In a clinical trial, one of the potential drugs to treat celiac disease reduced persistent symptoms in people already following a gluten-free diet. The trial involved 342 adults at 74 health care sites across North America.
Previous research suggested that larazotide acetate prevents a “leaky gut,” so gluten doesn’t reach underlying tissue and cause inflammation. In studies of patients being challenged with gluten, the drug reduced symptoms and celiac
disease antibodies.
This latest trial was first to test the drug in patients who had been following a gluten-free diet for at least 12 months but continued to experience symptoms. Participants randomly received a placebo, 0.5 mg, 1 mg or 2 mg of larazotide acetate three times daily.
More than one quarter of participants reported voluntarily eating gluten during the 20-week study, while more than half reported accidental exposure. They reported severity of various symptoms daily.
Patients receiving 0.5 mg showed improvement on the drug, reporting 26 percent fewer days with symptoms, averaging 1.73 days per week versus 2.38 days for patients on placebo. The same group also reported less severe symptoms. Patients with the most symptoms reported the most improvement.
Meanwhile patients in the groups receiving 1 or 2 mg reported no change in symptoms. Why higher doses are ineffective remains unclear, but this has been observed in similar drugs.
As a requirement for the study, candidates had to test positive for celiac disease antibodies so these levels could be monitored by blood tests. However most participants started with antibodies in a healthy or normal range. While the drug did not reduce patients’ antibodies in blood tests, it prevented any increase when they were exposed to gluten. More research is needed to investigate possible longer-term improvement.
The authors concluded larazotide deserves further study. It could also help people with other autoimmune diseases involving gut permeability, including Crohn’s disease, multiple sclerosis and type I diabetes.
Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM and Jurray JA, “Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial,” Gastroenterology, Jun 2014;148(7): 1311–9.e6, doi:10.1053/j.gastro.2015.02.008.
