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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT06001450

Collaborator

Aalborg University (Other)

400

Enrollment

Location

14.8

Anticipated Duration (Months)

27.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohns Disease Pregnancy Inflammatory Bowel Disease

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 23, 2024

Anticipated Study Completion Date :

Oct 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Pregnant people with Crohns disease (Case) 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) 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.

Outcome Measures

Primary Outcome Measures

Microplastics quantification [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 Outcome Measures

Alpha and beta diversity [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.
Fecal calprotectin analysis [1 year]
Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.