Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

NCT ID: NCT04159727

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2020-02-13

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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IBD or PD patients

20 patients suffering from IBD 10 patients suffering from PD

Group Type EXPERIMENTAL

stool and blood analysis

Intervention Type OTHER

High throughput sequencing and quantitative PCR

Asymptomatic subjects

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

Group Type ACTIVE_COMPARATOR

stool and blood analysis

Intervention Type OTHER

High throughput sequencing and quantitative PCR

Interventions

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stool and blood analysis

High throughput sequencing and quantitative PCR

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital Européen Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe HALFON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Marseille

Locations

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European Hospital

Marseille, Bouches-du Rhone, France

Site Status

Countries

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France

Other Identifiers

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18-22

Identifier Type: -

Identifier Source: org_study_id

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