Status:
RECRUITING
Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Aalborg University
Conditions:
Crohns Disease
Pregnancy
Eligibility:
All Genders
18+ years
Brief Summary
The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and gut microbiome in order to understand the role of this pollutant on the risk of developing inflammatory bo...
Detailed Description
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD is not well un...
Eligibility Criteria
Inclusion
- The ability to sign and date an informed consent form
- Be pregnant, or wishing to become pregnant in the near future and enroll the infant that the individual is pregnant with
- Aged 18 or older
- English-speaking (this observational study uses non-validated questionnaires that are only available in English)
- Of any ethnicity
- Be a spouse, related household member (sibling, parent, etc.) or a child of an enrolled pregnant person
Exclusion
- Individuals who are unable to give informed consent
- Be diagnosed with a pregnancy complication, such as intrauterine fetal demise/stillbirth, preeclampsia, hyperemesis gravidarum, or have an active infection, including chorioamnionitis or sepsis.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06001450
Start Date
August 15 2023
End Date
August 31 2027
Last Update
January 7 2026
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10128