NCT03850600Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 194 (actual)
- First submitted
- 15 Feb 2019
- Start date
- 30 Jan 2019
- Primary completion date
- Nov 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Crohn's disease
- NCT number
- NCT03850600
What you commit to
- Study type: Interventional
- Participants enrolled: 194
- From 30 Jan 2019 to the primary completion date, Nov 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic or steroid treatment at recruitment
- Scheduled cesarean section prior to gestational week 37
Other illness
- HIV/AIDS
- Active infection (including chorioamnionitis or sepsis)
- Alcohol use disorder
- Diagnosis of diabetes, renal disease, or intrauterine growth restriction
- Active perianal or extraintestinal disease
Other
- Inability to provide informed consent
- Multi-fetus pregnancy
- Fetal chromosomal or structural abnormalities
- Non-English speaking
Who the study is looking for
- Capacity to sign informed consent
- At least 18 years old
- Singleton pregnancy of less than 27-29 weeks gestation
- English-speaking
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Massachusetts Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.