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

PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Inflammatory Bowel Disease; Crohns Disease

Detailed Description

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD is not well understood, but believed to result from a complex relationship between genetics, environment, and gut microbiome alterations, resulting in a self-perpetuating, abnormal mucosal immune response. The incidence of IBD is rising in developing and recently developed countries, highlighting the importance of environmental exposures in determining disease risk. Microplastics, defined as plastic particles <5 mm in size, are ubiquitous pollutants with unclear implications towards human health. Emerging studies indicate substantial disruption of intestinal immune function and a proinflammatory milieu due to microplastics. Therefore, identifying, and characterizing microplastics in stool samples of individuals with CD alongside alterations in microbiome and calprotectin, which are events that occur prior to CD onset, is the initial step in exploring the impact of microplastics on IBD. Moreover, CD affects women during their reproductive years and 25% become pregnant after diagnosis. Given that maternal IBD diagnosis is one of the major risks of future IBD in offspring, it is critical to better understand if babies born to mothers with IBD have higher content of microplastics or other toxins in the stools and whether these levels correlate with those of their mothers during pregnancy.

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Mellissa Picker, BS; Phone Number: 86710 212-659-6710; Email: mellissa.picker@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Mellissa Picker, BS; Phone Number: 86710 212-659-6710; Email: mellissa.picker@mssm.edu
      • Principal Investigator: Manasi Agrawal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant people 18 years and older, with and without Crohns disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microplastics quantification	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha and beta diversity	Microbiome characterization - Bacterial DNA will be isolated from stool and sequenced to characterize the bacteria present in the microbiome. Alpha and beta diversity statistics will be reported.	1 year
Fecal calprotectin analysis	Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.	1 year

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Manasi Agrawal, MD, MS, Icahn School of Medicine at Mount Sinai

Publications and helpful links

Helpful Links

• You can find frequently asked questions, contact information and information about our lab at this link.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; pollution; microplastics; nanoplastics; environmental pollutants
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: STUDY-23-00245; 22-1179-00001 (Other Grant/Funding Number: Crohn's & Colitis Foundation Of America)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no blanket statement on IPD as some participants may opt out of data sharing in collaborations and the researchers will not be submitting data to any repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No