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NCT03850600 · ClinicalTrials.gov registry record · NA
Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
A NA study of Pregnancy and Crohn Disease, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- NA
- Development phase
- 194
- Enrollment target
- 2
- Study locations
NCT03850600: Active NA study of Pregnancy and Crohn Disease, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03850600 is a NA study of Pregnancy and Crohn Disease that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 194 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03850600, a NA study of Pregnancy and Crohn Disease, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Change in overall number of proteobacteria in pregnant CD patients at 4 years as compared to baseline
Conditions Studied
Interventions
- OTHER Diet-CD
Study Locations (2)
Massachusetts
- University of Massachusetts Medical School - Worcester
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2027-11 |
| Phase | NA |
What the registry record for NCT03850600 still lists
NCT03850600 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Diet-CD is the first listed.
NCT03850600 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT03850600 about?
NCT03850600 is a clinical study titled "Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease". 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 w...
What is the current status of trial NCT03850600?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 194 participants. The study started on 2019-01-30. Estimated completion is 2027-11.
What conditions does trial NCT03850600 study?
This clinical trial studies the following conditions: Pregnancy, Crohn Disease.
What interventions are being tested in trial NCT03850600?
The interventions under investigation include: Diet-CD (OTHER).
Who is sponsoring clinical trial NCT03850600?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03850600 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03850600's enrollment target sits among peer trials
194 90th of 191 higher than 102 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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