Last Updated on April 15, 2019 by Patricia Carter
Summary. If you are a pregnant mom (less than 27 weeks pregnant), or planning to become pregnant and wondering about a healthy pregnancy diet, please consider participating in the MELODY Trial, ClinicalTrials.gov Identifier: NCT03850600, WHICH IS NOW RECRUITING! I am super excited about this trial because it is recruiting pregnant aged women to participate in a study that will evaluate the efficacy of a diet intervention during the third trimester of pregnancy. The study’s goal is to determine if manipulation of the mothers microbiome, through diet, would benefit their baby. The diet aims to promote a healthier immune system during a critical time of immune system development. I am helping to recruit for the trial which will have 396 participants, having and not having autoimmune Crohn’s disease. Details for the trial are below. Guys, if the MELODY Trial works for IBD, to improve the microbiome and baby’s immune system, will this strategy work for other diseases?!? Please, do your part and share this info with your friends, daughters, gynecologists, GI docs, doulas… Lets load this cohort quickly and move the needle to make the future better for our next generation! We’ve messed so many things up microbiome-wise, WE OWE OUR CHILDREN THIS!
The principal investigators for the Melody Trial are Inga Peter, PhD (Icahn School of Medicine at Mount Sinai) and Barbara Olendzki, MPH, RD, LDN (Center of Applied Nutrition, Associate Professor, UMass Medical School).
The Melody Trial is based on the pilot Meconium Study, which I wrote about here. That study found increased risk of Crohn’s disease transmission to the newborn for mothers having Crohn’s disease.
Dr. Peter nicely sums the Melody Trial here–>
In sum, the Melody Trial (having 396 participants):
- Tests whether a non-invasive diet intervention (the
UMass IBD-AID diet) during the third trimester of pregnancy beneficially shifts the microbiome in mothers with Crohn’s disease and their babies. See, diet may play a role in the treatment of Crohn’s disease. Diet and health during pregnancy has impact on the baby’s microbiome. The infant early life microbiome informs its immune system development with long term health consequences. The initial newborn microbiome colonization occurs in-utero and at birth. The Melody Trial tests whether changing maternal diet during pregnancy promotes healthier immune system development in infants born to mother’s with Crohn’s disease. It especially looks at if increased risk of 4 to 8 times for IBD development in the newborn, is reduced with a change of maternal diet before the vaginal birth! - Any woman is elligible to participant if they are currently less than 27 weeks pregnant, or planning to become pregnant, having or not having Crohn’s disease. Exclusion criteria includes (this listing is not inclusive):
- Diagnosis of diabetes, renal disease, or intrauterine growth restriction.
- Active perianal or extraintestinal disease.
- Antibiotic or steroid treatment at recruitment.
- Scheduled cesarean section prior to gestational week 37.
- Participants with Crohn’s disease can follow their usual diet or the UMass IBD-AID diet.
- Participants do not need to live near the investigating labs. ALL information can be transmitted by mail or over the phone.
- Participants will be asked to fill out health status and dietary questionnaires. They will provide stool, saliva, breast milk, and other samples. They will also be asked to provide samples of their infant’s stool periodically throughout the first year of life.
- Participants will be compensated up to $200.
- Their time involved is from the beginning of the third trimester through the baby’s first birthday.
- Potential participants can contact me at biome393@gmail.com to learn more. They can also contact the principal researchers at themelodytrial@gmail.com, or phone 347-620-0210.
Conclusion: Have you wondered what is the HEALTHY PREGNANCY DIET?
Guys, if the MELODY Trial works for IBD, will this strategy work for other diseases?!? This trial seeks to learn if changing mom’s maternal diet improves the microbiome and baby’s immune system, decreasing the 4 to 8 times increased risk of transferance of IBD to the newborn for a mother having IBD! THIS STUDY IS GROUND BREAKING! Please, do your part and share this info with your friends, daughters, gynecologists, GI docs, doulas… Lets load this cohort quickly and move the needle to make the future better for our next generation! We’ve messed so many things up microbiome-wise, WE OWE OUR CHILDREN THIS!
Best in health through awareness,
Last updated: April 15, 2019 at 6:41 am to add in Vimeo video of Dr. Igna Peter discussing Melody Trial at Dr. Inga Peter – Rainin IBD Researcher.
