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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 Jun; 18:100573.CC

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32617430

Citation

Peter, Inga, et al. "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." Contemporary Clinical Trials Communications, vol. 18, 2020, p. 100573.
Peter I, Maldonado-Contreras A, Eisele C, et al. 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;18:100573.
Peter, I., Maldonado-Contreras, A., Eisele, C., Frisard, C., Simpson, S., Nair, N., Rendon, A., Hawkins, K., Cawley, C., Debebe, A., Tarassishin, L., White, S., Dubinsky, M., Stone, J., Clemente, J. C., Sabino, J., Torres, J., Hu, J., Colombel, J. F., & Olendzki, B. (2020). 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. Contemporary Clinical Trials Communications, 18, 100573. https://doi.org/10.1016/j.conctc.2020.100573
Peter I, et al. 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;18:100573. PubMed PMID: 32617430.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Peter,Inga, AU - Maldonado-Contreras,Ana, AU - Eisele,Caroline, AU - Frisard,Christine, AU - Simpson,Shauna, AU - Nair,Nilendra, AU - Rendon,Alexa, AU - Hawkins,Kelly, AU - Cawley,Caitlin, AU - Debebe,Anketse, AU - Tarassishin,Leonid, AU - White,Sierra, AU - Dubinsky,Marla, AU - Stone,Joanne, AU - Clemente,Jose C, AU - Sabino,Joao, AU - Torres,Joana, AU - Hu,Jianzhong, AU - Colombel,Jean-Frederic, AU - Olendzki,Barbara, Y1 - 2020/05/04/ PY - 2020/01/02/received PY - 2020/04/13/revised PY - 2020/04/26/accepted PY - 2020/7/4/entrez PY - 2020/7/4/pubmed PY - 2020/7/4/medline KW - CD, Crohn's disease KW - Crohn's disease KW - Diet KW - IBD, inflammatory bowel disease KW - IBD-AID™ KW - IBD-AID™, IBD Anti-inflammatory Diet KW - MELODY, Modulating Early Life Microbiome through Dietary Intervention in Pregnancy KW - Microbiome KW - Pregnancy SP - 100573 EP - 100573 JF - Contemporary clinical trials communications JO - Contemp Clin Trials Commun VL - 18 N2 - 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. SN - 2451-8654 UR - https://www.unboundmedicine.com/medline/citation/32617430/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 L2 - https://linkinghub.elsevier.com/retrieve/pii/S2451-8654(20)30057-0 DB - PRIME DP - Unbound Medicine ER -
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