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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10128
Mellissa Picker, BS
212-659-6710
Manasi Agrawal (PRINCIPAL_INVESTIGATOR)

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