ClinConnect ClinConnect Logo
Search / Trial NCT06001450

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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 14, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Microplastics Nanoplastics Pregnancy Pollution Environmental Pollutants

ClinConnect Summary

The PLANET Study is a clinical trial that aims to understand how microplastics, tiny pieces of plastic found in our environment, may affect intestinal inflammation and gut health in pregnant women. Researchers want to see if exposure to these pollutants could play a role in developing inflammatory bowel disease (IBD), which includes conditions like Crohn’s disease. By studying both pregnant women with and without Crohn's disease, the team hopes to learn more about how environmental factors can influence health, and this could lead to better prevention strategies for IBD and related illnesses.

To participate in this study, you need to be at least 18 years old, pregnant or planning to become pregnant soon, and able to speak English. You should also be able to provide consent to join the study. If you have certain pregnancy complications or cannot give informed consent, you may not be eligible. Participants will be asked to complete questionnaires about their health and environment. This research could help shed light on the impact of pollution on gut health during pregnancy, which is important for both mothers and their babies.

Gender

ALL

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.

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Manasi Agrawal, MD, MS

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported