Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson (Medibiote1)

September 15, 2025 updated by: Hôpital Européen Marseille

Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : IBD and Parkinson

Inflammatory bowel diseases (IBD) and Parkinson disease (PD) are complex and multifactorial pathologies. Gut microbiota seems to play an active role. Indeed the digestive microbiota of patients with IBD or PD exhibits different compositions compared with asymptomatic subjects.

Bacterial translocation from gut to blood has been reported.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators designed a case-control study to investigate the digestive microbiota and bacterial translocation during IBD and PD. The investigators want to evaluate gut microbiota bacteria involved in dysbiosis and bacterial translocation during IBD and PD. The investigators want to identify bacterial populations that can serve as biomarkers for clinical practice.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches-du Rhone
      • Marseille, Bouches-du Rhone, France, 13003
        • European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • PD patients : age < or = 60 years
  • asymptomatic subjects : no chronic disease
  • asymptomatic subjects : no treatment

Exclusion Criteria:

  • severe anemia (Hb<7g/L)
  • people who don't read french
  • pregnant women
  • people treated by antibiotic, probiotic or prebiotic during the 2 month before inclusion
  • people with any diagnosed or treated pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBD or PD patients
20 patients suffering from IBD 10 patients suffering from PD
Other: stool and blood analysis
High throughput sequencing and quantitative PCR
Active Comparator: Asymptomatic subjects
30 asymptomatic subjects matched to patients on age, sexe and BMI
Other: stool and blood analysis
High throughput sequencing and quantitative PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16S RNA sequencing in stool sample
Time Frame: 2 years
16S RNA sequencing to identify species constituting the microbiota in the stool
2 years
16S RNA sequencing in blood sample
Time Frame: 2 years
16S RNA sequencing to identify species constituting the microbiota in the blood
2 years
Stool quantification of key bacteria associated with intestinal barrier permeability.
Time Frame: 2 years
To determine stool rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR
2 years
Blood quantification of key bacteria associated with intestinal barrier permeability.
Time Frame: 2 years
To determine blood rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Investigators

  • Principal Investigator: Philippe HALFON, MD, PhD, Hôpital Européen Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Actual)

February 13, 2020

Study Completion (Actual)

February 13, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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