Inflammatory Bowel DiseasesMedibiote1NCT04159727
Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson
A study testing stool and blood analysis in people with Inflammatory Bowel Diseases and Parkinson Disease, run by Hôpital Européen Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Parkinson Disease
- What is being tested?
- stool and blood analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2019to 13 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD patients : age < or = 60 years
- asymptomatic subjects : no chronic disease
- asymptomatic subjects : no treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Parkinson Disease
- Being tested
- stool and blood analysis
- Keywords
- gut microbiota, Bacterial translocation
- Medical subject headings
- Inflammatory Bowel Diseases, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool and blood analysisOther
High throughput sequencing and quantitative PCR
| Study group | Role | What they receive |
|---|---|---|
| IBD or PD patients | Experimental | 20 patients suffering from IBD 10 patients suffering from PD Receives: Other: stool and blood analysis |
| Asymptomatic subjects | Active comparator | 30 asymptomatic subjects matched to patients on age, sexe and BMI Receives: Other: stool and blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S RNA sequencing in stool sample
16S RNA sequencing to identify species constituting the microbiota in the stool
Measured: 2 years
16S RNA sequencing in blood sample
16S RNA sequencing to identify species constituting the microbiota in the blood
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start28 Mar 2019
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe HALFON, MD, PhD, Principal investigator, Hôpital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159727
- Sponsor's protocol ID
- 18-22
- Acronym
- Medibiote1
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : IBD and Parkinson
- ClinicalTrials.gov ID
- NCT04159727
- Acronym / sponsor ID
- Medibiote1 / 18-22
- Conditions
- Inflammatory Bowel Diseases, Parkinson Disease
- Keywords
- gut microbiota, Bacterial translocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD or PD patients | Experimental | Other: stool and blood analysis20 patients suffering from IBD 10 patients suffering from PD |
| Asymptomatic subjects | Active comparator | Other: stool and blood analysis30 asymptomatic subjects matched to patients on age, sexe and BMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PD patients : age < or = 60 years
- asymptomatic subjects : no chronic disease
- asymptomatic subjects : no treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool and blood analysisHigh throughput sequencing and quantitative PCR | Other | Asymptomatic subjects, IBD or PD patients |
Primary outcome
16S RNA sequencing in stool sample
Time frame: 2 years
16S RNA sequencing to identify species constituting the microbiota in the stool
16S RNA sequencing in blood sample
Time frame: 2 years
16S RNA sequencing to identify species constituting the microbiota in the blood
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe HALFON, MD, PhD principal investigator
Hôpital Européen Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stool and blood analysis in people with Inflammatory Bowel Diseases and Parkinson Disease, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16S RNA sequencing in stool sample (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.