Diet-CD for Crohn's Disease During Pregnancy
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?
How is the Diet-CD treatment for Crohn's disease during pregnancy different from other treatments?
What data supports the effectiveness of the treatment Diet-CD for Crohn's Disease during pregnancy?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Intervention
Participants in Arm 1 undergo an 8-10 week dietary intervention during the last trimester of pregnancy
No Intervention
Participants in Arm 2 and Arm 3 follow their usual diet with no intervention
Follow-up
Participants are monitored for changes in microbiome and inflammation markers postpartum
What Are the Treatments Tested in This Trial?
Interventions
- Diet-CD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
University of Massachusetts, Worcester
Collaborator