Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

Parkinson Disease Clinical Trial

— Medibiote1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159727
• Other study ID #: 18-22 Medibiote 1
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: November 2019
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Inflammatory Bowel Diseases
• Parkinson Disease

Intervention

Other:
• stool and blood analysis
High throughput sequencing and quantitative PCR

Locations

Country	Name	City	State
France	European Hospital	Marseille	Bouches-du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16S RNA sequencing in stool sample	16S RNA sequencing to identify species constituting the microbiota in the stool	2 years
Primary	16S RNA sequencing in blood sample	16S RNA sequencing to identify species constituting the microbiota in the blood	2 years
Primary	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	2 years
Primary	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	2 years