Actively Recruiting
PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-07
46
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
A
Aalborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The PLANET Study investigates the impact of microplastics on intestinal inflammation and the gut microbiome to better understand their role in increasing the risk of inflammatory bowel disease (IBD), including Crohn's disease (CD). This research aims to clarify how environmental pollutants contribute to IBD and to develop new strategies for prevention. The study focuses on pregnant individuals, given the risk maternal IBD poses to offspring, and examines microplastics in stool samples alongside changes in the microbiome and inflammation markers. Participants include pregnant people with Crohn's disease and a control group of pregnant people without Crohn's or other inflammatory bowel diseases. Both groups enroll with the infant they are carrying. The study observes differences in microplastics quantity, microbiome diversity, and fecal calprotectin levels between these groups. Researchers collect stool samples and other data over one year to explore these relationships. Participants will provide stool samples and answer questionnaires in English during the study. Researchers will measure microplastics in stool samples and analyze microbiome diversity and calprotectin as markers of intestinal inflammation. The study monitors participants and their infants for one year to assess environmental toxin exposure and related intestinal changes. This observational study does not involve treatment and lasts about one year per participant.
CONDITIONS
Brief Title
Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign and date an informed consent form
- Pregnant or planning to become pregnant soon, enrolling with the infant they are carrying
- Aged 18 years or older
- English-speaking
- Of any ethnicity
- Spouse, related household member, or child of an enrolled pregnant person
You will not qualify if you...
- Unable to give informed consent
- Diagnosed with pregnancy complications such as fetal demise, preeclampsia, hyperemesis gravidarum, or active infections including chorioamnionitis or sepsis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants are monitored during pregnancy to collect stool samples and assess microplastics, microbiome diversity, and inflammatory markers.
Multiple visits during pregnancy and post-delivery for sample collection and assessments
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10128
Actively Recruiting
Research Team
M
Mellissa Picker, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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