Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT06001450
- Status
- Recruiting
Conditions
- Crohns Disease
- Inflammatory Bowel Disease
- Pregnancy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
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 bowel disease (IBD) as well as other diseases. With this information, the researchers hope to characterize better the role of environmental pollutants on IBD and develop novel strategies towards prevention.
Key Dates
- Start date
- Aug 15, 2023
- Status verified
- Oct 2025
- Primary completion
- Oct 31, 2026
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 46 participants (estimated)
Arms
- Arm: Pregnant people with Crohns disease (Case)Arm 1 is pregnant people with Crohns disease who enroll with the infant that they are pregnant with at the time.
- Arm: Pregnant people without Crohns disease (Control)Arm 2 is the control arm of pregnant people without Crohns disease and other inflammatory bowel diseases who enroll with the infant that they are pregnant with at the time.
Primary Outcome Measure
Microplastics quantification [ Time Frame: 1 year ]
Central Contacts
- Mellissa Picker, BS212-659-6710
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10128 | Manasi Agrawal (PRINCIPAL_INVESTIGATOR) |
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