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

NCT06001450 | Recruiting

• 2 other identifiers: STUDY-23-0024522-1179-00001
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohns Disease; Pregnancy; Inflammatory Bowel Disease

Keywords

microplastics; nanoplastics; pregnancy; pollution; environmental pollutants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Alpha and beta diversity

  1 year

• Fecal calprotectin analysis

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant people 18 years and older, with and without Crohns disease.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Aalborg University: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Saliva, Breast milk, Whole Blood (optional), Cord Blood (optional), Placenta (optional)

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Manasi Agrawal, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mellissa Picker, BS

CONTACT

212-659-6710; mellissa.picker@mssm.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)