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| ID | Type | Description | Link |
|---|---|---|---|
| 22-1179-00001 | Other Grant/Funding Number | Crohn's & Colitis Foundation Of America |
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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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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.
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD is not well understood, but believed to result from a complex relationship between genetics, environment, and gut microbiome alterations, resulting in a self-perpetuating, abnormal mucosal immune response. The incidence of IBD is rising in developing and recently developed countries, highlighting the importance of environmental exposures in determining disease risk. Microplastics, defined as plastic particles <5 mm in size, are ubiquitous pollutants with unclear implications towards human health. Emerging studies indicate substantial disruption of intestinal immune function and a proinflammatory milieu due to microplastics. Therefore, identifying, and characterizing microplastics in stool samples of individuals with CD alongside alterations in microbiome and calprotectin, which are events that occur prior to CD onset, is the initial step in exploring the impact of microplastics on IBD. Moreover, CD affects women during their reproductive years and 25% become pregnant after diagnosis. Given that maternal IBD diagnosis is one of the major risks of future IBD in offspring, it is critical to better understand if babies born to mothers with IBD have higher content of microplastics or other toxins in the stools and whether these levels correlate with those of their mothers during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Fecal calprotectin analysis |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant people 18 years and older, with and without Crohns disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mellissa Picker, BS | Contact | 212-659-6710 | 86710 | mellissa.picker@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Manasi Agrawal, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10128 | United States |
There is no blanket statement on IPD as some participants may opt out of data sharing in collaborations and the researchers will not be submitting data to any repositories.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Stool, Saliva, Breast milk, Whole Blood (optional), Cord Blood (optional), Placenta (optional)
Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation. |
| 1 year |