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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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 population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

46 Participants
are grouped into 2 trial groups
Group A: Pregnant people with Crohns disease (Case)
Group B: Pregnant people without Crohns disease (Control)

Trial outcomes

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).

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

Fecal calprotectin analysis

Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.

Time frame
1 year

Other outcomes

Sponsors and contacts

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