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

Last updated: October 22, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT06001450
STUDY-23-00245
22-1179-00001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 infantthat the individual is pregnant with

  • Aged 18 or older

  • English-speaking (this observational study uses non-validated questionnaires thatare only available in English)

  • Of any ethnicity

  • Be a spouse, related household member (sibling, parent, etc.) or a child of anenrolled pregnant person

Exclusion

Exclusion Criteria:

  • Individuals who are unable to give informed consent

  • Be diagnosed with a pregnancy complication, such as intrauterine fetaldemise/stillbirth, preeclampsia, hyperemesis gravidarum, or have an activeinfection, including chorioamnionitis or sepsis.

Study Design

Total Participants: 42
Study Start date:
August 15, 2023
Estimated Completion Date:
June 16, 2025

Study 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.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10128
    United States

    Active - Recruiting

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