Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease (NCT03850600)
The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's Disease, will test whether a non-invasive dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies during the sensitive time window of infant immune system development, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies. Through this trial, the study team hopes to better understand the origin of the initial gut bacterial colonization in babies, providing potential intervention targets to prevent Crohn's disease development in high risk individuals.
Who can join: Review the eligibility criteria below.
Location: University of Massachusetts Medical School — Worcester, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
- Diet-CD (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Massachusetts Medical School — Worcester, Massachusetts
- Icahn School of Medicine at Mount Sinai — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn Disease
- Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease — Lutherville, Maryland
- Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial — New Haven, Connecticut
- A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease — Portland, Oregon
- Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) — Ottawa, Ontario
- A Long-term Extension Study of Ustekinumab in Pediatric Participants — Atlanta, Georgia
- Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease — Atlanta, Georgia
Explore by condition: All Crohn Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.