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

Primary Purpose

Inflammatory Bowel Diseases, Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

stool and blood analysis

About this trial

This is an interventional screening trial for Inflammatory Bowel Diseases focused on measuring gut microbiota, Bacterial translocation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

European Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBD or PD patients

Asymptomatic subjects

Arm Description

20 patients suffering from IBD 10 patients suffering from PD

30 asymptomatic subjects matched to patients on age, sexe and BMI

Outcomes

Primary Outcome Measures

16S RNA sequencing in stool sample

16S RNA sequencing to identify species constituting the microbiota in the stool

16S RNA sequencing in blood sample

16S RNA sequencing to identify species constituting the microbiota in the blood

Stool quantification of key bacteria associated with intestinal barrier permeability.

To determine stool rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR

Blood quantification of key bacteria associated with intestinal barrier permeability.

To determine blood rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR

Secondary Outcome Measures

Full Information

NCT ID

NCT04159727

First Posted

October 16, 2019

Last Updated

May 12, 2021

Sponsor

Hôpital Européen Marseille

1. Study Identification

Unique Protocol Identification Number

NCT04159727

Brief Title

Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

Acronym

Medibiote1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

March 28, 2019 (Actual)

Primary Completion Date

February 13, 2020 (Actual)

Study Completion Date

February 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hôpital Européen Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases, Parkinson Disease

Keywords

gut microbiota, Bacterial translocation

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBD or PD patients

Arm Type

Experimental

Arm Description

20 patients suffering from IBD 10 patients suffering from PD

Arm Title

Asymptomatic subjects

Arm Type

Active Comparator

Arm Description

30 asymptomatic subjects matched to patients on age, sexe and BMI

Intervention Type

Other

Intervention Name(s)

stool and blood analysis

Intervention Description

High throughput sequencing and quantitative PCR

Primary Outcome Measure Information:

Title

16S RNA sequencing in stool sample

Description

16S RNA sequencing to identify species constituting the microbiota in the stool

Time Frame

2 years

Title

16S RNA sequencing in blood sample

Description

16S RNA sequencing to identify species constituting the microbiota in the blood

Time Frame

2 years

Title

Stool quantification of key bacteria associated with intestinal barrier permeability.

Description

To determine stool rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR

Time Frame

2 years

Title

Blood quantification of key bacteria associated with intestinal barrier permeability.

Description

To determine blood rates of Faecalibacterium prausnitzii, Akkermansia muciniphila, Bacteroides fragilis, Clostridium difficile, Mycobacterium avium paratuberculosis and Escherischia coli by qPCR

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe HALFON, MD, PhD

Organizational Affiliation

Hôpital Européen Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

European Hospital

City

Marseille

State/Province

Bouches-du Rhone

ZIP/Postal Code

13003

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

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