Dietary Intervention
Diet-CD for Crohn's Disease
University of Massachusetts Medical School, Worcester, MA
Targeting 2 different conditionsDiet-CDN/ARecruitingLed by Ana Maldonado-Contreras, PhDResearch Sponsored by Icahn School of Medicine at Mount SinaiEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Singleton pregnancy of less than 27-29 weeks gestation
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether a dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies.
Eligible Conditions
- Crohn's Disease
- Pregnancy
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are pregnant with only one baby and are less than 27-29 weeks pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in overall number of proteobacteria
Secondary outcome measures
Alternative Healthy Eating Index
Calprotectin level
Harvey Bradshaw index (HBI)
+4 moreAwards & 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-CDActive Control1 Intervention
Usual diet with no intervention
Group III: No-Diet-ControlActive Control1 Intervention
Unaffected controls at the same gestational stage will follow usual diet and no intervention
Find a site
Who is running the clinical trial?
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
51 Previous Clinical Trials
63,626 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
323 Previous Clinical Trials
758,246 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
816 Previous Clinical Trials
510,695 Total Patients Enrolled
Ana Maldonado-Contreras, PhDPrincipal Investigator
University of Massachusetts, WorcesterInga Peter, PhD5.045 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Torrance Memorial Medical Center
Medical School - State University of New York, Brooklyn, Doctor of Medicine
New York Medical College, Residency in Ophthalmology
1 Previous Clinical Trials
2,145 Total Patients Enrolled
5Patient Review
They are very knowledgeable and have great bedside manner.
Barbara Olendzki, RD,MPH, LDNPrincipal Investigator
University of Massachusetts, WorcesterMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted for participation in this experiment?
"This study, which was initially published on January 30th 2019, is still searching for participants. Clinicaltrials.gov indicates that the information associated with this medical trial has been recently updated on November 1st 2022."
Answered by AI
How many participants have been included in this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this research initiative, which was originally published on January 30th 2019, is currently recruiting patients. 396 participants need to be enrolled from two separate medical centres."
Answered by AI