A gastroenterologist at the University of Miami Miller School of Medicine is leading a new clinical trial of a healthy plant-based diet for adults being treated for moderate to severe ulcerative colitis, a serious disease of the intestinal tract.
“Preliminary studies suggest that this novel diet intervention, along with medical treatment, may be beneficial for patients with ulcerative colitis,” said Oriana M. Damas, M.D., assistant professor of medicine and director of translational studies for the UM Crohn's and Colitis Center in the Division of Gastroenterology.
“Medical therapy for ulcerative colitis has improved significantly, but there are still many patients who respond poorly to medications,” said Dr. Damas. “It may be that diet moderates how patients respond to their medications but clinical trials right now looking at the effect of a drug on inflammation do not control for what patients eat. Therefore, this is the first clinical trial to see whether a standardized diet can reduce inflammation and help induce remission during the start of a new medication.”
The goal of the eight-week trial is to identify whether a novel, plant-based diet improves clinical response to tofacinitib, a medication now being used to treat ulcerative colitis patients. The trial will involve 50 participants who are starting tofacinitib therapy at the UM Crohn’s and Colitis Center.
Half the participants will be asked to follow the new diet and the other half will follow a different healthy diet as a control group. “In both cases, participants will receive step-by-step diet information from a nutritionist,” said Dr. Damas. “Patients will also provide information on their current diets, keep food diaries and monitor their symptoms during the course of the trial.”
During the study, participants will provide stool samples so researchers can measure the level of inflammation in their intestinal tissues, as well as the nature of their microbiomes, the healthy and unhealthy bacteria in their gastrointestinal tracts.
“Our center has done prior diet intervention studies in patients with inflammatory bowel disease and currently my colleague, Dr. Maria Abreu, is conducting another clinical trial looking at the effect of a healthy low-fat diet on Crohn’s disease patients,” said Dr. Damas. “At our center we emphasize nutrition as an important component of treatment for inflammation.”
Dr. Damas hopes the findings from the new study may point to new strategies for therapeutic interventions that offer a comprehensive approach to treating acute flares. “Perhaps a patient with an unhealthy diet at the start of the study might show greater improvement than a patient who is already eating well,” she said. “We will also measure the intestinal microbiome and individual patient characteristics to determine whether baseline patient measures predict who will do best with this diet.
“If we can find even a modest improvement, we can try it on patients with less severe disease,” she said. “This will also help us advance our goals of tailoring treatment to individual patients through precision medicine.”
For more information about the study, email XeljanzAndDiet@miami.edu.