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.

CD, Crohn's disease Crohn's disease Diet IBD, inflammatory bowel disease IBD-AID™ IBD-AID™, IBD Anti-inflammatory Diet MELODY, Modulating Early Life Microbiome through Dietary Intervention in Pregnancy Microbiome Pregnancy

Journal

Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157

Informations de publication

Date de publication:
Jun 2020
Historique:
received: 02 01 2020
revised: 13 04 2020
accepted: 26 04 2020
entrez: 4 7 2020
pubmed: 4 7 2020
medline: 4 7 2020
Statut: epublish

Résumé

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.

Identifiants

pubmed: 32617430
doi: 10.1016/j.conctc.2020.100573
pii: S2451-8654(20)30057-0
pii: 100573
pmc: PMC7322804
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100573

Subventions

Organisme : NIGMS NIH HHS
ID : R25 GM086262
Pays : United States

Déclaration de conflit d'intérêts

No competing interests.

Références

Gastroenterology. 2019 Aug;157(2):440-450.e8
pubmed: 31170412
Clin Gastroenterol Hepatol. 2014 Oct;12(10):1592-600
pubmed: 24107394
Public Health Nutr. 2014 Aug;17(8):1689-96
pubmed: 23941862
Gastroenterology. 2015 May;148(6):1087-106
pubmed: 25597840
Nat Biotechnol. 2019 Aug;37(8):852-857
pubmed: 31341288
Am J Gastroenterol. 1997 Dec;92(12):2241-4
pubmed: 9399762
Lancet. 2003 May 24;361(9371):1831
pubmed: 12781578
PLoS Comput Biol. 2012;8(6):e1002358
pubmed: 22719234
J Immunol. 2017 Nov 15;199(10):3516-3524
pubmed: 29021375
Med Clin North Am. 2016 Nov;100(6):1199-1215
pubmed: 27745590
J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):516-21
pubmed: 24897165
Inflamm Bowel Dis. 2012 Apr;18(4):703-8
pubmed: 21538718
Evol Bioinform Online. 2007 Feb 17;2:121-8
pubmed: 19455206
Gastroenterology. 2019 Jun;156(8):2190-2197.e10
pubmed: 30772341
Gut. 2020 Jan;69(1):42-51
pubmed: 31036757
Am J Gastroenterol. 2015 Mar;110(3):444-54
pubmed: 25732419
PLoS One. 2010 Apr 01;5(4):e9964
pubmed: 20376357
Proc Natl Acad Sci U S A. 2014 Feb 11;111(6):2247-52
pubmed: 24390544
Int J Nurs Pract. 2019 Nov 5;:e12797
pubmed: 31691405
Int J Mol Med. 2013 Jun;31(6):1471-6
pubmed: 23588209
Clin Exp Allergy. 2009 Dec;39(12):1842-51
pubmed: 19735274
Am J Health Behav. 2016 May;40(3):291-301
pubmed: 27103408
Int J Epidemiol. 2003 Dec;32(6):1054-62
pubmed: 14681273
Dig Dis. 2014;32(4):389-94
pubmed: 24969285
Inflamm Bowel Dis. 2016 May;22(5):1129-36
pubmed: 26914438
J Nutr. 2012 Jun;142(6):1009-18
pubmed: 22513989
Pediatr Res. 2015 Jan;77(1-2):189-95
pubmed: 25310759
J Immunol. 2013 Sep 15;191(6):3200-9
pubmed: 23935191
Inflamm Bowel Dis. 2013 May;19(6):1322-9
pubmed: 23399738
N Engl J Med. 1994 Jun 30;330(26):1841-5
pubmed: 8196726
Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17
pubmed: 25732745
Nat Methods. 2016 Jul;13(7):581-3
pubmed: 27214047
Am J Gastroenterol. 1955 Apr;23(4):344-60
pubmed: 14361377
J Crohns Colitis. 2014 Oct;8(10):1179-207
pubmed: 24909831
Gut. 1998 Jul;43(1):29-32
pubmed: 9771402
J Am Diet Assoc. 1999 Nov;99(11):1406-11
pubmed: 10570678
J Acad Nutr Diet. 2018 Sep;118(9):1591-1602
pubmed: 30146071
Ann Behav Med. 2003 Aug;26(1):1-7
pubmed: 12867348
Annu Rev Public Health. 2003;24:289-313
pubmed: 12415147
Aliment Pharmacol Ther. 2017 Nov;46(9):780-789
pubmed: 28892171
Clin Gastroenterol Hepatol. 2010 Apr;8(4):357-63
pubmed: 20096379
Nat Biotechnol. 2015 Oct;33(10):1045-52
pubmed: 26344404
Genome Med. 2016 Aug 09;8(1):77
pubmed: 27503374
Appl Environ Microbiol. 2011 Sep;77(18):6718-21
pubmed: 21784919
PLoS One. 2011;6(8):e23031
pubmed: 21829685
Nat Biotechnol. 2015 Oct;33(10):1053-60
pubmed: 26368049
J Am Diet Assoc. 2001 Feb;101(2):216-22
pubmed: 11271695
J Crohns Colitis. 2012 Aug;6(7):771-6
pubmed: 22398090
Nat Microbiol. 2016 Apr 04;1:16031
pubmed: 27572644
Am J Prev Med. 2004 Aug;27(2 Suppl):88-101
pubmed: 15275677
Am J Gastroenterol. 2015 Apr;110(4):564-71
pubmed: 25803400
Pediatr Gastroenterol Hepatol Nutr. 2017 Mar;20(1):1-13
pubmed: 28401050
PLoS One. 2017 Apr 17;12(4):e0175675
pubmed: 28414763
Lancet. 2015 Nov 7;386(10006):1825-34
pubmed: 26342731
J Am Diet Assoc. 1978 Jul;73(1):48-55
pubmed: 659761
Nutrients. 2019 Nov 04;11(11):
pubmed: 31689999
J Am Diet Assoc. 2001 Mar;101(3):332-41
pubmed: 11269614
Aliment Pharmacol Ther. 2011 Jun;33(12):1332-9
pubmed: 21507029
Nutr Metab Cardiovasc Dis. 2019 Apr;29(4):325-333
pubmed: 30777308
Science. 2016 Apr 29;352(6285):539-44
pubmed: 27126036
Gastroenterology. 2019 Aug;157(2):295-297
pubmed: 31254503
Am J Gastroenterol. 2017 Sep;112(9):1412-1422
pubmed: 28741616
Gastroenterology. 2017 Feb;152(2):313-321.e2
pubmed: 27793607
Nutr J. 2014 Jan 16;13:5
pubmed: 24428901
Autoimmun Rev. 2014 Apr-May;13(4-5):467-71
pubmed: 24424189
Microbiome. 2018 Jul 5;6(1):109
pubmed: 29973274
J Crohns Colitis. 2017 Oct 1;11(10):1205-1212
pubmed: 28525622
World J Gastroenterol. 2013 Nov 21;19(43):7652-60
pubmed: 24282355
Cochrane Database Syst Rev. 2019 Feb 08;2:CD012839
pubmed: 30736095
J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91
pubmed: 24048168
Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):573-584
pubmed: 28743984
Gastroenterology. 2015 May;148(5):938-947.e1
pubmed: 25620670
Inflamm Bowel Dis. 2006 Apr;12(4):304-10
pubmed: 16633052
Nat Methods. 2018 Nov;15(11):962-968
pubmed: 30377376
Appl Environ Microbiol. 2005 Dec;71(12):8228-35
pubmed: 16332807
J Gastroenterol. 2014 Apr;49(4):638-45
pubmed: 23636735
Nat Biotechnol. 2013 Sep;31(9):814-21
pubmed: 23975157
Chronic Dis Transl Med. 2017 Aug 26;3(3):154-158
pubmed: 29063070
Pediatrics. 2012 Oct;130(4):e794-803
pubmed: 23008454
J Gastroenterol Hepatol. 2010 Feb;25(2):252-8
pubmed: 20136989
J Nutr. 2009 Dec;139(12):2365-72
pubmed: 19864399
Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7401-6
pubmed: 20385819
Pediatrics. 2015 Jan;135(1):e92-8
pubmed: 25452656

Auteurs

Inga Peter (I)

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.

Ana Maldonado-Contreras (A)

Department of Microbiology and Physiology Systems, University of Massachusetts Medical School, Worcester, MA, USA.

Caroline Eisele (C)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Christine Frisard (C)

Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.

Shauna Simpson (S)

Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.

Nilendra Nair (N)

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.

Alexa Rendon (A)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Kelly Hawkins (K)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Caitlin Cawley (C)

Department of Microbiology and Physiology Systems, University of Massachusetts Medical School, Worcester, MA, USA.

Anketse Debebe (A)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Leonid Tarassishin (L)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Sierra White (S)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Marla Dubinsky (M)

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.

Joanne Stone (J)

Department of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Jose C Clemente (JC)

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.

Joao Sabino (J)

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.

Joana Torres (J)

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.

Jianzhong Hu (J)

Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Jean-Frederic Colombel (JF)

Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.

Barbara Olendzki (B)

Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.

Classifications MeSH