Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Recruiting · NCT06001450 · Observational (researchers observe without assigning treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States