NCT06001450 Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
| NCT ID | NCT06001450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Crohns Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 46 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 46 participants in total. It began in 2023-08-15 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Manasi Agrawal, MD, MS
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06001450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohns Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06001450 currently recruiting?
Yes, NCT06001450 is actively recruiting participants. Contact the research team at mellissa.picker@mssm.edu for enrollment information.
Where is the NCT06001450 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06001450 clinical trial?
NCT06001450 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Manasi Agrawal, MD, MS at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 46 participants.