Abstract

A dietary intervention to improve the microbiome composition of pregnant women with Crohn's disease and their offspring: The MELODY (Modulating Early Life Microbiome through Dietary Intervention in Pregnancy) trial design

Contemp Clin Trials Commun. 2020 May 4;18:100573. doi: 10.1016/j.conctc.2020.100573.eCollection 2020 Jun.

Inga Peter 1 2, Ana Maldonado-Contreras 3, Caroline Eisele 1, Christine Frisard 4, Shauna Simpson 4, Nilendra Nair 1 5, Alexa Rendon 1, Kelly Hawkins 1, Caitlin Cawley 3, Anketse Debebe 1, Leonid Tarassishin 1, Sierra White 1, Marla Dubinsky 6 7, Joanne Stone 8, Jose C Clemente 1 2 9, Joao Sabino 1 6 10, Joana Torres 6 11, Jianzhong Hu 1, Jean-Frederic Colombel 6, Barbara Olendzki 4

 
     

Author information

  • 1Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 2Institute for Data Science and Genomic Technology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 3Department of Microbiology and Physiology Systems, University of Massachusetts Medical School, Worcester, MA, USA.
  • 4Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
  • 5Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  • 6Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 7Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 8Department of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 9The Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
  • 10Department of Gastroenterology, University Hospitals of Leuven, Leuven, Belgium.
  • 11Division of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal.

Abstract

Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic condition of the gastrointestinal tract that is caused by the loss of mucosal tolerance towards the commensal bacteria resulting in inflammatory responses. It has long been postulated that the gut microbiota, a complex and dynamic population of microorganisms, plays a key role in the pathogenesis of IBD. Maternal diagnosis of IBD has been identified as the greatest risk factor for IBD in offspring increasing the odds of developing the disease >4.5-fold. Moreover, babies born to mothers with IBD have demonstrated reduced gut bacterial diversity. There is accumulating evidence that the early life microbiota colonization is informed by maternal diet within the 3rd trimester of pregnancy. While babies born to mothers with IBD would pose an ideal cohort for intervention, no primary prevention measures are currently available. Therefore, we designed the MELODY (Modulating Early Life Microbiome through Dietary Intervention in Pregnancy) trial to test whether the IBD-AID™ dietary intervention during the last trimester of pregnancy can beneficially shift the microbiome of CD patients and their babies, thereby promoting a strong, effective immune system during a critical time of the immune system development. We will also test if favorable changes in the microbiome can lead to a reduced risk of postpartum CD relapse and lower mucosal inflammation in the offspring. This study will help create new opportunities to foster a healthy microbiome in the offspring at high risk of other immune-mediated diseases, potentially reducing their risk later in life.

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