← Back to Search

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
Must not have
Antibiotic or steroid treatment at recruitment
Active perianal or extraintestinal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a special diet during pregnancy can improve gut health in women with Crohn's disease and their babies. The goal is to create a healthier balance of gut bacteria, which may help reduce disease relapse in mothers and lower gut inflammation in babies. The study will collect various samples to analyze the effects of the diet.

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.
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.
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 below
Select...
I am 18 years old or older.
Select...
I am pregnant with one baby and less than 29 weeks along.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking antibiotics or steroids.
Select...
I have active symptoms around my anus or outside my intestines.
Select...
My fetus has been diagnosed with chromosomal or structural abnormalities.
Select...
I do not have any active infections.
Select...
I am living with HIV/AIDS.
Select...
I do not speak English.
Select...
I have been diagnosed with diabetes, kidney disease, or had a baby who was small for gestational age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in overall number of proteobacteria
Secondary study objectives
Alternative Healthy Eating Index
Calprotectin level
Harvey Bradshaw index (HBI)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease include dietary interventions, medications, and sometimes surgery. Dietary interventions, such as the low FODMAP diet and specific carbohydrate diet, aim to reduce inflammation and symptoms by altering the gut microbiota composition. These diets limit certain carbohydrates that are poorly absorbed and fermented in the gut, which can exacerbate symptoms. Medications like anti-inflammatory drugs, immunosuppressants, and biologics target the immune response to reduce inflammation and prevent flare-ups. Understanding these mechanisms is crucial for Crohn's Disease patients as it helps tailor treatments to manage symptoms effectively and improve quality of life.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
895 Previous Clinical Trials
537,235 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
62 Previous Clinical Trials
99,081 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
361 Previous Clinical Trials
992,748 Total Patients Enrolled

Media Library

Diet-CD (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03850600 — N/A
Crohn's Disease Research Study Groups: No-Diet-Control, Diet-CD, No-Diet-CD
Crohn's Disease Clinical Trial 2023: Diet-CD Highlights & Side Effects. Trial Name: NCT03850600 — N/A
Diet-CD (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850600 — N/A
~29 spots leftby Oct 2025