NCT04159727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
Last Updated

September 16, 2025

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

October 16, 2019

Last Update Submit

September 15, 2025

Conditions

Inflammatory Bowel DiseasesParkinson Disease

Keywords

gut microbiotaBacterial translocation

Outcome Measures

Primary Outcomes (4)

  • 16S RNA sequencing in stool sample

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

    2 years

  • 16S RNA sequencing in blood sample

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

    2 years

  • 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

  • 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

Study Arms (2)

IBD or PD patients

EXPERIMENTAL

20 patients suffering from IBD 10 patients suffering from PD

Other: stool and blood analysis

Asymptomatic subjects

ACTIVE COMPARATOR

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

Other: stool and blood analysis

Interventions

stool and blood analysisOTHER

High throughput sequencing and quantitative PCR

Asymptomatic subjectsIBD or PD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PD patients : age \< or = 60 years
  • asymptomatic subjects : no chronic disease
  • asymptomatic subjects : no treatment

You may not qualify if:

  • severe anemia (Hb\<7g/L)
  • people who don't read french
  • pregnant women
  • people with any diagnosed or treated pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Marseille, Bouches-du Rhone, 13003, France

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesParkinson Disease

Interventions

DefecationHematologic Tests

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Philippe HALFON, MD, PhD

    Hôpital Européen Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

November 12, 2019

Study Start

March 28, 2019

Primary Completion

February 13, 2020

Study Completion

February 13, 2020

Last Updated

September 16, 2025

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)