What side effects are associated with this type of intervention?

Common dietary treatments for Crohn's Disease, such as the low FODMAP diet, specific carbohydrate diet (SCD), and Mediterranean diet, generally have a good safety profile but can lead to nutritional deficiencies if not properly managed. The low FODMAP diet may cause initial digestive discomfort and is challenging to maintain long-term. The SCD can be restrictive, potentially leading to inadequate nutrient intake. The Mediterranean diet is well-tolerated but may not suit everyone. Consulting with a dietitian is essential to avoid these risks.

What prior FDA approvals exist?

FDA-approved treatments for Crohn's Disease include biologics like anti-TNF agents (e.g., infliximab, adalimumab), integrin receptor antagonists (e.g., vedolizumab), and interleukin inhibitors (e.g., ustekinumab). Immunomodulators such as azathioprine and methotrexate are also used. While these treatments focus on immune modulation, dietary interventions like the Specific Carbohydrate Diet (SCD) and the low-FODMAP diet are being studied for their potential to modulate gut microbiota and reduce inflammation, offering a complementary approach to traditional pharmacotherapy.

What other types of research exist?

Promising novel alternatives to dietary intervention for Crohn's Disease patients include: 1) Biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), and integrin inhibitors (e.g., vedolizumab). 2) Small molecule drugs like Janus kinase (JAK) inhibitors (e.g., tofacitinib). 3) Fecal microbiota transplantation (FMT), which has shown potential in altering gut microbiota composition and reducing inflammation. 4) Stem cell therapy, particularly mesenchymal stem cells, which are being investigated for their immunomodulatory properties. These alternatives offer various mechanisms of action and may be considered based on individual patient profiles and disease severity.

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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

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

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I am 18 years old or older.

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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:

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I am currently taking antibiotics or steroids.

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I have active symptoms around my anus or outside my intestines.

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My fetus has been diagnosed with chromosomal or structural abnormalities.

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I do not have any active infections.

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I am living with HIV/AIDS.

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I do not speak English.

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I have been diagnosed with diabetes, kidney disease, or had a baby who was small for gestational age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

0 / 9Eligibility criteria met

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.