Exploring the impact of microplastics on pregnant women with Crohn's disease
Official title: PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation
Run by Icahn School of Medicine at Mount Sinai · NCT06001450 · Data updated 2026-11-12
This study is trying to see how microplastics and toxins in the environment affect gut health in pregnant women with Crohn's disease and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 15, 2023 |
| Main results expected | October 31, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT06001450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women or those planning to become pregnant, particularly those with a diagnosis of Crohn's disease.
✕Probably not a fit
Patients with pregnancy complications or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PLANET Study investigates how microplastics and environmental toxins affect intestinal inflammation and the gut microbiome in pregnant women, particularly those with Crohn's disease. By analyzing stool samples from these women and their infants, the study aims to understand the correlation between microplastic exposure and the risk of developing inflammatory bowel disease (IBD). This observational study will utilize non-validated questionnaires and stool analysis to gather data on the presence of microplastics and other pollutants. The findings could lead to better prevention strategies for IBD and related conditions.
Why it matters
Potential benefit: If successful, this study could provide insights into the environmental factors contributing to IBD, potentially leading to improved prevention strategies for affected individuals.
How similar studies have gone: While the impact of microplastics on human health is an emerging field, this specific approach to studying its effects on pregnant women with Crohn's disease is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Manasi Agrawal, MD, MS — Icahn School of Medicine at Mount Sinai
- Study coordinator: Mellissa Picker, BS
- Email: mellissa.picker@mssm.edu
- Phone: 212-659-6710
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.