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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159727
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Parkinson Disease Other: stool and blood analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : IBD and Parkinson
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IBD or PD patients
20 patients suffering from IBD 10 patients suffering from PD
Other: stool and blood analysis
High throughput sequencing and quantitative PCR

Active Comparator: Asymptomatic subjects
30 asymptomatic subjects matched to patients on age, sexe and BMI
Other: stool and blood analysis
High throughput sequencing and quantitative PCR




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159727


Contacts
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Contact: Wahiba bidaut (0)4 13 42 73 35 ext +33 w.bidaut@hopital-europeen.fr
Contact: Lucie Molet (0)413428165 ext +33 l.molet@alphabio.fr

Locations
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France
European Hospital Recruiting
Marseille, Bouches-du Rhone, France, 13003
Contact: Wahiba BIDAUT    (0)4 13 42 73 35 ext +33    w.bidaut@hopital-europeen.fr   
Contact: Lucie Molet    (0)413428165 ext +33    l.molet@alphabio.fr   
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
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Principal Investigator: Philippe HALFON, MD, PhD Hôpital Européen Marseille
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Responsible Party: Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT04159727    
Other Study ID Numbers: 18-22 Medibiote 1
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital Européen Marseille:
gut microbiota
Bacterial translocation
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Parkinson Disease
Dysbiosis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pathologic Processes