Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

Colorectal cancer is the third most common cancer worldwide, yet it was the second leading cause of cancer-related deaths in 2020. The average French population faces a colorectal cancer risk partly linked to lifestyle factors. The majority of colorectal cancer cases (approximately 85%) are not caused by hereditary mutations. Environmental factors, such as lifestyle or diet (notably through endocrine disruptors), can affect the gut microbiota (a collection of microorganisms - bacteria, viruses, parasites, and fungi - residing in the intestinal environment) and lead to disturbances in its composition, referred to as dysbiosis. While the mechanisms underlying dysbiosis associated with colorectal cancer remain poorly understood, the involvement of certain ingested substances, known as xenobiotics, is increasingly suspected, including endocrine disruptors. Among the most common endocrine disruptors found in water and food are parabens and phthalates, which will be examined in detail in this study. These substances may be directly involved in the development of colorectal cancer and in response to its treatment.

The main objective of this studie is to characterize the relationship between colorectal cancer diagnosis, activity/composition of the gut microbiota, and patients' exposure to selected endocrine disruptors, particularly parabens and phthalates.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Scheduled endoscopy during the inclusion visit or within 18 months following this consultation.

Signed consent from the patient after clear and fair information about the study is provided.

Patient is free of guardianship, curatorship, or dependency.

Patient is covered by a social security system or through a third party.

Disqualifiers

Patients receiving treatment for chronic inflammatory bowel disease;

Patients with hereditary colorectal cancer;

Use of antibiotics, probiotics, or prebiotics within four weeks prior to stool sample collection;

Patients who have undergone neoadjuvant chemotherapy or radiotherapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collection of biological samples and clinical data

    Other intervention

    * Collection of a hair sample * Collection of urine * Collection of stool samples * Collection of clinical, paraclinical data, and exposure questionnaire

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Patient with colorectal cancerOther 1 intervention
Group B: Patient without suspected colorectal cancerOther 1 intervention

Trial outcomes

Primary outcomes

1

Association between faecal microbiota disruption and exposure to endocrine disruptors

Association between disruptions in the composition and/or activity of the faecal microbiota (sequencing and metabolome analysis) and exposure to endocrine disruptors (measured in urine and stool samples) in patients with colorectal cancer and in controls

Time frame
1 month/patient (maximum time between enrolment visit and stool collection)

Secondary outcomes

1

Describe the accumulated exposome

LC/MS on hair samples

Time frame
1 day/patient
2

Describe gut microbiota composition

From stool samples

Time frame
1 month/patient (maximum time between enrolment visit and stool collection)
3

Detect differences in pro-carcinogenic bacteria

In stool samples

Time frame
1 month/patient (maximum time between enrolment visit and stool collection)
4

Correlation metabolome / gut microbiota in patients with colorectal cancer

Analysis of the correlation between the metabolome and gut microbiota in colorectal cancer patients

Time frame
1 month/patient (maximum time between enrolment visit and stool collection)

Other outcomes

Sponsors and contacts

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Poitiers University Hospital

Lead sponsor

University of Poitiers - Laboratoire Ecologie et Biologie des Interactions (EBI) - UMR CNRS 7267

Collaborator