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Dietary Intervention
Diet-CD for Crohn's Disease During Pregnancy
N/A
Waitlist Available
Led By Ana Maldonado-Contreras, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
Singleton pregnancy of less than 27-29 weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will test whether a dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies.
Who is the study for?
This trial is for English-speaking pregnant women over 18 with Crohn's Disease, carrying a single baby and not past the 27-29 week mark. They must be able to consent and can't have used antibiotics or steroids recently, nor have diabetes, renal disease, growth-restricted babies, multiple fetuses, certain infections like HIV/AIDS or plan an early C-section.Check my eligibility
What is being tested?
The MELODY Trial investigates if changing diet during pregnancy affects gut bacteria in mothers with Crohn's Disease and their babies. It aims to see if this reduces the mother's relapse risk after birth and lessens gastrointestinal issues in infants by influencing early immune development.See study design
What are the potential side effects?
Since this study involves dietary changes rather than medication, side effects may include digestive discomfort or food-related allergic reactions. However, these are expected to be minimal compared to drug interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am pregnant with one baby and less than 29 weeks along.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in overall number of proteobacteria
Secondary outcome measures
Alternative Healthy Eating Index
Calprotectin level
Harvey Bradshaw index (HBI)
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Diet-CDExperimental Treatment1 Intervention
dietary intervention: 8-10 weeks of diet intervention
Group II: No-Diet-ControlActive Control1 Intervention
Unaffected controls at the same gestational stage will follow usual diet and no intervention
Group III: No-Diet-CDActive Control1 Intervention
Usual diet with no intervention
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,092 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,724 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
342 Previous Clinical Trials
976,416 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antibiotics or steroids.I am 18 years old or older.I am pregnant with one baby and less than 29 weeks along.You have a problem with alcohol.I have active symptoms around my anus or outside my intestines.My fetus has been diagnosed with chromosomal or structural abnormalities.I do not have any active infections.I am living with HIV/AIDS.I do not speak English.I am able to understand and sign the consent form.I have been diagnosed with diabetes, kidney disease, or had a baby who was small for gestational age.
Research Study Groups:
This trial has the following groups:- Group 1: No-Diet-Control
- Group 2: Diet-CD
- Group 3: No-Diet-CD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted for participation in this experiment?
"This study, which was initially published on January 30th 2019, is still searching for participants. Clinicaltrials.gov indicates that the information associated with this medical trial has been recently updated on November 1st 2022."
Answered by AI
How many participants have been included in this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this research initiative, which was originally published on January 30th 2019, is currently recruiting patients. 396 participants need to be enrolled from two separate medical centres."
Answered by AI
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