Peter Inga, Maldonado-Contreras Ana, Eisele Caroline, Frisard Christine, Simpson Shauna, Nair Nilendra, Rendon Alexa, Hawkins Kelly, Cawley Caitlin, Debebe Anketse, Tarassishin Leonid, White Sierra, Dubinsky Marla, Stone Joanne, Clemente Jose C, Sabino Joao, Torres Joana, Hu Jianzhong, Colombel Jean-Frederic, Olendzki Barbara
Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
Institute for Data Science and Genomic Technology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
Contemp Clin Trials Commun. 2020 May 4;18:100573. doi: 10.1016/j.conctc.2020.100573. eCollection 2020 Jun.
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.
克罗恩病（CD）是炎症性肠病（IBD）的一种，是胃肠道的一种慢性疾病，由对共生菌的黏膜耐受性丧失导致炎症反应引起。长期以来，人们一直推测肠道微生物群（一个复杂且动态的微生物群体）在IBD的发病机制中起关键作用。母亲患IBD被认为是后代患IBD的最大风险因素，患病几率增加超过4.5倍。此外，患有IBD的母亲所生的婴儿肠道细菌多样性降低。越来越多的证据表明，孕期第三个月母亲的饮食会影响早期生命中的微生物群定植。虽然患有IBD的母亲所生的婴儿将成为理想的干预队列，但目前尚无一级预防措施。因此，我们设计了MELODY（通过孕期饮食干预调节早期生命微生物组）试验，以测试孕期最后三个月的IBD - AID™饮食干预是否能有益地改变CD患者及其婴儿的微生物组，从而在免疫系统发育的关键时期促进强大、有效的免疫系统。我们还将测试微生物组的有利变化是否能降低产后CD复发的风险以及降低后代的黏膜炎症。这项研究将有助于创造新的机会，在有患其他免疫介导疾病高风险的后代中培养健康的微生物组，可能降低他们日后患这些疾病的风险。
