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

Pregnancy Clinical Trial

— PLANET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001450
• Other study ID #: STUDY-23-00245
• Secondary ID: 22-1179-00001
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: September 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Mellissa Picker, BS
• Phone: 212-659-6710
• Email: mellissa.picker[@]mssm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 23, 2024
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease
• Inflammation
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Pregnancy

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Aalborg University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microplastics quantification	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).	1 year
Secondary	Alpha and beta diversity	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.	1 year
Secondary	Fecal calprotectin analysis	Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.	1 year

External Links

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