Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06001450

Pregnant Women With and Without Crohns Disease to Explore 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10128, United States

Location status: Recruiting

Location contact

Manasi Agrawal

PRINCIPAL_INVESTIGATOR

Mellissa Picker, BS

CONTACT

[email protected]

212-659-6710 ext. 86710

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Microplastics quantification

    Time frame: 1 year

    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).

Secondary outcomes

  1. Alpha and beta diversity

    Time frame: 1 year

    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.

  2. Fecal calprotectin analysis

    Time frame: 1 year

    Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mellissa Picker, BS

CONTACT

[email protected]

212-659-6710 ext. 86710

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Acronym: PLANET

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.