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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Fecal calprotectin analysis
Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
Aalborg University
Collaborator