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OpenTrials
Completed

NCT Number: NCT04159727

Gut Microbiota Dysbiosis and Translocation During 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.

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Key information

Conditions

Inflammatory Bowel Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital

Marseille, Bouches-du Rhone, 13003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stool and blood analysis

Other

High throughput sequencing and quantitative PCR

Primary outcomes

  1. 16S RNA sequencing in stool sample

    Time frame: 2 years

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

  2. 16S RNA sequencing in blood sample

    Time frame: 2 years

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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study title

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

Acronym: Medibiote1

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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