PLANET Study: Microplastics and Crohn's Disease in Pregnant Women

This observational study, called the PLANET Study, is looking at how tiny plastic particles (microplastics) might affect inflammation in the intestines and the balance of bacteria in the gut (gut microbiome). Researchers want to understand if these pollutants play a role in developing inflammatory bowel disease (IBD), like Crohn's disease. They will measure the amount of microplastics in stool samples. This study is for pregnant women, or those planning to become pregnant soon, who are at least 18 years old and speak English. The goal is to better understand how environmental factors contribute to IBD and help develop ways to prevent it. The study is currently recruiting participants.

Study design
This is an observational study with a planned enrollment of 46 participants. It is not testing a specific drug or intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Microplastics will be measured at 1 year, suggesting a follow-up period of at least one year.

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NCT06001450

Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation

Recruiting
Not specifiedAges 18+Observational
Icahn School of Medicine at Mount Sinai
~46 participants
Updated 2026-01-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microplastics quantification
Measured over 1 year
Crohns Disease
Pregnancy
Inflammatory Bowel Disease
1 sites across 1 states
New York1
  • Manasi Agrawal, MD, MS · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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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.
  • Microplastics quantification1 year

    Measuring the concentration, size and shape distributions of microplastics in the stool samples of women with CD, healthy controls and any relatives (spouses and siblings of the infant).