Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06001450

Conditions

Crohns Disease

Pregnancy

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Crohns Disease

Pregnancy

Inflammatory Bowel Disease

Study ID

NCT06001450

Start date

Aug 15, 2023

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

46 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant people with Crohns disease (Case)

Arm 1 is pregnant people with Crohns disease who enroll with the infant that they are pregnant with at the time.

Pregnant people without Crohns disease (Control)

Arm 2 is the control arm of pregnant people without Crohns disease and other inflammatory bowel diseases who enroll with the infant that they are pregnant with at the time.

Primary outcome measure

  • Microplastics quantification [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mellissa Picker, BS

212-659-6710mellissa.picker@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10128

Contacts

Mellissa Picker, BS

212-659-6710mellissa.picker@mssm.edu

Principal Investigator:

Manasi Agrawal

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jan 7, 2026

Last verified

Oct, 2025

Keywords

  • microplastics
  • nanoplastics
  • pregnancy
  • pollution
  • environmental pollutants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-01-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.