and Barbara Olendzki, RD, MPH |
Researchers at UMass Medical School and Icahn School of Medicine at Mount Sinai are conducting a clinical trial to determine if an anti-inflammatory diet may reduce the risk of pregnant women with Crohn’s disease relapsing after child birth and of disease transmission to the baby.
The Modulating Early Life Microbiome through Prenatal Dietary Intervention in Crohn’s Disease trial (MELODY) will evaluate whether a noninvasive diet intervention called IBD Anti-Inflammatory Diet (IBD-AID) adhered to during the third trimester of pregnancy can beneficially shift the bacterial flora of the microbiome in mothers with Crohn’s disease and their babies.
“We hypothesize that we could reduce the risk of babies developing the disease if we modulate the mother’s and baby’s microbiome early in life during the critical window of immune system development,” said Ana Maldonado-Contreras, PhD, assistant professor in microbiology & physiological systems and principal investigator for the trial.
Dr. Maldonado-Contreras will work with co-investigator Barbara Olendzki, RD, MPH, associate professor of medicine in the Division of Preventive and Behavioral Medicine and director of the UMMS Center for Applied Nutrition, and in collaboration with researchers from Icahn School of Medicine.
Crohn’s disease is a type of inflammatory bowel disease and a chronic condition of the gastrointestinal tract that can cause debilitating pain, bloating and diarrhea. Medications can alleviate symptoms but are not curative and come with side effects. Babies born to mothers with Crohn’s are at a substantially increased risk of developing the disease.
In 2018, Maldonado-Contreras and Olendzki studied IBD-AID, which follows a nutritional regimen that restricts the intake of complex carbohydrates such as refined sugar, gluten-based grains and certain starches from the diet. The carbohydrates are thought to provide a substrate for proinflammatory bacteria. Preliminary results from that clinical trial indicate that IBD-AID is able to promote shifts in the gut microbiota that correlate with reduction of IBD disease activity in adults. Maldonado-Contreras and her team are currently analyzing data from a large patient cohort to further underpin the relationship of IBD-AID, the microbiome and disease severity.
“It seems to be very promising and we see the need in our participants. If we can lower the risk of babies developing the disease by diet, that’s what we want. We also want to understand, from the scientific perspective, the mechanistic side of it,” Maldonado-Contreras said.
The 2018 clinical trial sprang from a small, retrospective case study of the diet published in 2014 in Nutrition Journal, in which all of the participants who adhered to the diet for at least four weeks experienced significant reduction in their symptoms, and were able to discontinue at least one of their IBD medications.
For the current trial, samples, such as stool, blood, saliva and breast milk, will be collected from participants during the third-trimester of pregnancy, at delivery and for 12 months after birth. Participants will also answer questionnaires. Olendzki, creator of the IBD-AID diet, will supervise the delivery of adequate nutrition for the participants and advice on any specific dietary requirements and adjustments.
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