Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
Observational · No treatment assigned · 1 site · Icahn School of Medicine at Mount Sinai
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohns Disease, Pregnancy and Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 46 participants are expected to take part.
- Start date: 2023-08-15.
- Main results expected around 2026-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Microplastics quantification (1 year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohns Disease; Pregnancy; Inflammatory Bowel Disease |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Collaborators | Aalborg University |
| Enrollment | 46 (estimated) |
| Start date | 2023-08-15 |
| Primary completion (est.) | 2026-10-31 |
| First posted | 2023-08-21 |
| Last updated | 2026-01-07 |
| Official title | PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation |
| ClinicalTrials.gov ID | NCT06001450 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York, New York | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.