Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Parkinson Disease
• Interventions: Other: stool and blood analysis

• Registration Number: NCT04159727
• Lead Sponsor: Hôpital Européen Marseille

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.

Study Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2019-10-16
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBD or PD patients	stool and blood analysis	20 patients suffering from IBD 10 patients suffering from PD
Asymptomatic subjects	stool and blood analysis	30 asymptomatic subjects matched to patients on age, sexe and BMI

Primary Outcome Measures

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

Trial Locations

Locations (1)

European Hospital; 🇫🇷 Marseille, Bouches-du Rhone, France