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Recruiting NCT06001450

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

Observational Crohns Disease Pregnancy Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Crohns Disease, Pregnancy, Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Microplastics quantification [Time frame: 1 year]
Secondary outcome measures (2)
  • Alpha and beta diversity [Time frame: 1 year]
  • Fecal calprotectin analysis [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT06001450 · STUDY-23-00245 · 22-1179-00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗