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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 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.

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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.

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

FieldValue
Enrollment Target 194 participants
Start Date 2019-01-30
Est. Completion 2027-11
Phase NA

What the Registry Record Tells You About NCT03850600

The ClinicalTrials.gov registry entry for NCT03850600 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (78% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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