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STUDY-23-00245

Pregnant women with and without crohns disease to explore the role of plastics and toxins in intestinal inflammation
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06001450
microplastics
nanoplastics
pregnancy
pollution
environmental pollutants
Source : Importé depuis le centre
Recrutement ouvert
Dernière modification : 2025/06/10
Type de recherche

Observationnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • Pregnant people with Crohns disease (Case)
    État du recrutement
    unknown
    Pregnant people without Crohns disease (Control)
    État du recrutement
    unknown
    Données à jour depuis : 10 juin 2025

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 10 juin 2025
    Données à jour depuis : 12 juin
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06001450