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

Mount Sinai Health System

Status: Enrolling

Conditions: Inflammatory Bowel Disease; Crohns Disease; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT06001450

22-1179-00001 (Other Grant/Funding Number)

STUDY-23-00245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Pregnant people with Crohns disease (Case)

Description:

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)

Description:

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.