Diet-CD for Crohn's Disease During Pregnancy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special diet called Diet-CD during pregnancy can improve gut health for women with Crohn's disease and their babies. The goal is to determine if this diet reduces the chance of disease flare-ups for the mother after birth and lowers the risk of gut issues in their babies. Participants will either follow the special diet or maintain their usual eating habits. Pregnant women who speak English, have Crohn's disease, and are less than 27-29 weeks pregnant might be suitable for this study.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could benefit future mothers and their babies.

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.

What prior data suggests that this dietary intervention is safe for pregnant women with Crohn's disease?

Research has shown that dietary treatments for Crohn's disease during pregnancy are generally safe. One study described a pregnant woman with Crohn's who followed a specific diet without medication and did not experience major problems. Other reports suggest that methods like total parenteral nutrition, which involves feeding directly into a vein, have successfully provided adequate nutrition to pregnant women with Crohn's.

Although studies on this specific diet during pregnancy are limited, available evidence suggests it is well-tolerated. Always consult a healthcare provider before starting any new treatment to ensure its suitability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Diet-CD treatment is unique because it focuses on dietary intervention rather than traditional medication for managing Crohn's disease during pregnancy. Researchers are excited about this approach because it offers a non-pharmacological option that could minimize potential risks to both the mother and the developing fetus. Unlike standard treatments, which often include medications like corticosteroids or immunosuppressants, Diet-CD aims to manage symptoms through a tailored diet, potentially reducing medication side effects and enhancing overall well-being.

What evidence suggests that this dietary intervention could be effective for Crohn's disease during pregnancy?

Research has shown that a special diet during pregnancy may improve gut health in women with Crohn's disease. In this trial, participants will either follow the Diet-CD intervention or continue with their usual diet without intervention. Previous studies have found that dietary changes can positively affect the gut microbiome, the community of bacteria in the gut. Other research suggests that consuming a variety of foods during pregnancy might reduce the risk of inflammatory conditions in children. One case report indicated that a specific diet could serve as the sole treatment for active Crohn's disease during pregnancy. These findings suggest that diet plays a crucial role in managing Crohn’s disease and could help reduce complications for both mothers and their babies. ^{1 6 7 8 9}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10344521/

Novel Use of the Crohn's Disease Exclusion Diet Plus ... We examine the outcomes of CDED with PEN as monotherapy for active CD during pregnancy. CASE REPORT. A 35-year-old woman with a history of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S000291652400858X

Maternal diet in pregnancy and the risk of inflammatory ... Our findings suggest that a higher maternal diet diversity in pregnancy may be associated with a lower risk of UC in the offspring.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8135214/

Review of pregnancy in Crohn's disease and ulcerative colitis A recent meta-analysis found 33% lower live birth rates after ART in women with CD compared with the general population, and 51% lower in women with previous CD ...

4. withpower.com withpower.com/trial/phase-crohn-disease-2019-09da5

Diet-CD for Crohn's Disease During Pregnancy 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 ...

5. cghjournal.org cghjournal.org/article/S1542-3565%2825%2900322-2/fulltext

Global Consensus Statement on the Management of ... In women with inflammatory bowel disease, we recommend counseling that active disease increases the risk of infertility as compared with ...

6. cghjournal.org cghjournal.org/article/S1542-3565(25)00322-2/fulltext

Global Consensus Statement on the Management of ... We suggest that pregnant women with inflammatory bowel disease take low-dose aspirin by 12 to 16 weeks' gestation to prevent preterm ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5486164/

Managing Crohn's Disease during Pregnancy - PMC With active disease during conception, pregnancy will lead to deterioration of the course of CD in two-thirds of the patients and will increase the risk of ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212826314000323

Is dietary treatment of Crohn's disease safe in pregnancy? ... There have been few reports on pregnancy in Crohn's patients treated with diet. Total parenteral nutrition has been used successfully to supplement nutritional ...

9. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(24)00858-X/pdf

Maternal diet in pregnancy and the risk of inflammatory bowel ... Hazard ratios (HRs) for IBD, Crohn disease (CD), and ulcerative colitis (UC) by maternal diet diversity, quality, and intake amounts of ...