Clinical trial NCT06001450: Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Official title: PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohns Disease
Pregnancy
Inflammatory Bowel Disease
Keywords: microplastics
nanoplastics
pregnancy
pollution
environmental pollutants
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2023-08-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant people 18 years and older, with and without Crohns disease.

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.

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.

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.

Primary outcomes:
measure: Microplastics quantification
timeFrame: 1 year
Secondary outcomes:
measure: Alpha and beta diversity
timeFrame: 1 year
measure: Fecal calprotectin analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Manasi Agrawal, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: