Status:
ACTIVE_NOT_RECRUITING
Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
University of Massachusetts, Worcester
Conditions:
Crohn Disease
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 microbiot...
Detailed Description
The study design is a three-arm, prospective, pre-post intervention trial. Crohn's Disease (CD) patients at 27-29 weeks of pregnancy will self-select to Arm 1 or Arm 2. Controls will be in Arm 3. 1. ...
Eligibility Criteria
Inclusion
- Capacity to sign informed consent
- At least 18 years old
- Singleton pregnancy of less than 27-29 weeks gestation
- English-speaking
Exclusion
- Inability to provide informed consent
- HIV/AIDS
- Multi-fetus pregnancy
- Fetal chromosomal or structural abnormalities
- Active infection (including chorioamnionitis or sepsis)
- Alcohol use disorder
- Diagnosis of diabetes, renal disease, or intrauterine growth restriction
- Non-English speaking
- Active perianal or extraintestinal disease
- Antibiotic or steroid treatment at recruitment
- Scheduled cesarean section prior to gestational week 37
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2027
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03850600
Start Date
January 30 2019
End Date
November 1 2027
Last Update
February 6 2025
Active Locations (2)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029