Diet-CD for Crohn's Disease During Pregnancy

Recruiting at 1 trial location

Overseen By Inga Peter, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Antibiotics, Steroids

Disqualifiers: HIV/AIDS, Diabetes, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antibiotics or steroids at the time of recruitment.

Is the Crohn's Disease Exclusion Diet safe during pregnancy?

The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition (PEN) was used safely in a pregnant woman with Crohn's disease, leading to remission and a healthy birth weight without drug therapy. ^{1 2 3 4 5}

How is the Diet-CD treatment for Crohn's disease during pregnancy different from other treatments?

Diet-CD is unique because it combines the Crohn's Disease Exclusion Diet with partial enteral nutrition, allowing for the management of Crohn's disease during pregnancy without the use of drugs, which is different from traditional treatments that often rely on medication. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Diet-CD for Crohn's Disease during pregnancy?

A case study showed that the Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition (PEN) helped a pregnant woman with Crohn's disease achieve remission and maintain a healthy pregnancy without the use of drugs. ^{1 2 3 4 7}

Who Is on the Research Team?

Ana Maldonado-Contreras, PhD

Principal Investigator

University of Massachusetts, Worcester

Inga Peter, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Barbara Olendzki, RD,MPH, LDN

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English-speaking

I am pregnant with one baby and less than 29 weeks along.

I am able to understand and sign the consent form.

Exclusion Criteria

I am currently taking antibiotics or steroids.

You have a problem with alcohol.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants in Arm 1 undergo an 8-10 week dietary intervention during the last trimester of pregnancy

8-10 weeks

Nutritional counseling and training sessions

No Intervention

Participants in Arm 2 and Arm 3 follow their usual diet with no intervention

8-10 weeks

Follow-up

Participants are monitored for changes in microbiome and inflammation markers postpartum

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Diet-CD

Trial Overview 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.

How Is the Trial Designed?

Group I: Diet-CD Experimental Treatment 1 Intervention

dietary intervention: 8-10 weeks of diet intervention

Group II: No-Diet-Control Active Control 1 Intervention

Unaffected controls at the same gestational stage will follow usual diet and no intervention

Group III: No-Diet-CD Active Control 1 Intervention

Usual diet with no intervention

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Surgery for Crohn's disease during pregnancy: A nationwide survey. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

Adherence to medical treatment in relation to pregnancy, birth outcome & breastfeeding behavior among women with Crohn's disease. [2017]

3. Romania pubmed.ncbi.nlm.nih.gov

Managing Crohn's Disease during Pregnancy. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Novel Use of the Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition for the Treatment of Crohn's Disease During Pregnancy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of Crohn's disease in pregnant women: drug and multidisciplinary approaches. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Therapy of complicated Crohn's disease during pregnancy--an interdisciplinary challenge. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

[Pregnancy and delivery in patients with Crohn's disease who had a history of abdominal surgery]. [2021]