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Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

NCT03850600 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-02-06

No results posted yet for this 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

  • Crohn Disease
  • Pregnancy

Interventions

OTHER

Diet-CD

CD patients will self-select into the intervention arm to follow the diet for 8-10 weeks during their third trimester of pregnancy.

Sponsors & Collaborators

Principal Investigators

  • Inga Peter, PhD · Icahn School of Medicine at Mount Sinai

  • Barbara Olendzki, RD,MPH, LDN · University of Massachusetts, Worcester

  • Ana Maldonado-Contreras, PhD · University of Massachusetts, Worcester

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03850600 on ClinicalTrials.gov