Systemic SclerosisScleroBiotiqueNCT04132206
Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
An observational study of Systemic Sclerosis, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- stool sampling
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2019to 3 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with ScS according to ACR criteria,and healthy volunteers without diagnosis of ScS or any other chronic disease
Who may be able to join
- For ScS patients:
- Patients with ScS according to ACR criteria.
- Patients over 18 years old.
- Patients who have signed the consent to participate in this study.
- For control subjects:
- Persons without diagnosis of ScS or any other chronic disease.
- Persons over 18 years old.
- Persons who have signed the consent to participate in this study
Who cannot join
- 1. Persons with severe anemia (Hb < 7 g/dL). 2. Persons who cannot read French. 3. For control subjects: Persons with a particular symptom (as an example of digestive disorders), or under long-term treatment related to another pathology.
- 4. Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
- 5. Persons referred to the article L1121-5 to 1121-8 of the Public health code, namely :
- Pregnant, women in labour and breastfeeding mothers.
- Persons deprived of their liberty by a judicial or administrative decision.
- Persons undergoing psychiatric follow-up.
- Minors
- Persons of full-age who are subject to a legal protection measure or who are unable to express their consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Chloé STAVRIS, MD, 06 23 01 64 25, c.stavris@hopital-europeen.fr
Eya TOUMY, PhD student, 04 13 42 81 50, e.toumi@alphabio.fr
About this study
Official title: ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.
Read the detailed description
This is an explorative, prospective, monocentric open-label study qualified as interventional researches at minimal risks and constraints (called in French RIPH, category 2).
This is a study of the gut microbiota and its characteristics in ScS patients, compared to control subjects (without ScS or other chronic diseases), matched on age and sex.
Participants provided two stool samples: one collected the day of inclusion and a second, six months later.
In parallel with the microbiota analysis, a clinical (digestive and extra digestive signs, severity) and biological characterization of the ScS will be carried out by the team of internists. This medical evaluation will be completed by an interview with a dietician to inform about the participant's eating habits, and any changes in the 7 days preceding the stool collection.
Microbial profiles will be obtained from the sequencing data using the specialized tools DADA2 and Kraken.
The search of characteristic signature of ScS will be performed by comparing ScS patients and healthy controls using a discriminant linear analysis (LDA) using the specialized tool LEfSe Main objective is to identify, through longitudinal follow-up, significant differences in the composition of the intestinal microbiota of ScS patients and healthy control subjects (matched on age and sex) in order to define a microbial signature specific to the ScS.
Secondary objectives are to study the stability over time of the identified microbial signatures, and to determine a correlation between the composition of the microbiota obtained in the ScS patient and the severity of his symptoms (diffuse skin disease, pulmonary interstitial disease, digestive disease...)
- Conditions
- Systemic Sclerosis
- Being tested
- stool sampling
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool samplingOther
Participants will provide two stool samples: one collected the day of inclusion and a second, six months later
| Study group | Role | What they receive |
|---|---|---|
| ScS patients | Patients will provide two stool samples: one collected the day of inclusion and a second, six months later Receives: Other: stool sampling | |
| Healthy subjects | Healthy subjects will provide one stool sample at inclusion. Receives: Other: stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences on gut microbiota composition (bacterial populations) of ScS overtime, at different taxonomic levels (from phyla to species if technique allows) versus healthy controls.
The patient participation at the study will last 7 months, but healthy volunteers will provide stool sample only once at study entry and won't be followed after that.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start8 Oct 2019
- Primary completion3 Jun 2026 (estimated)
- Study completion3 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé STAVRIS, MD, Principal investigator, Hôpital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132206
- Sponsor's protocol ID
- 18-30
- Acronym
- ScleroBiotique
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2019
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04132206
- Acronym / sponsor ID
- ScleroBiotique / 18-30
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 3 Jun 2026 (estimated)
- First posted
- 18 Oct 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.
Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.
Detailed description
This is an explorative, prospective, monocentric open-label study qualified as interventional researches at minimal risks and constraints (called in French RIPH, category 2).
This is a study of the gut microbiota and its characteristics in ScS patients, compared to control subjects (without ScS or other chronic diseases), matched on age and sex.
Participants provided two stool samples: one collected the day of inclusion and a second, six months later.
In parallel with the microbiota analysis, a clinical (digestive and extra digestive signs, severity) and biological characterization of the ScS will be carried out by the team of internists. This medical evaluation will be completed by an interview with a dietician to inform about the participant's eating habits, and any changes in the 7 days preceding the stool collection.
Microbial profiles will be obtained from the sequencing data using the specialized tools DADA2 and Kraken.
The search of characteristic signature of ScS will be performed by comparing ScS patients and healthy controls using a discriminant linear analysis (LDA) using the specialized tool LEfSe Main objective is to identify, through longitudinal follow-up, significant differences in the composition of the intestinal microbiota of ScS patients and healthy control subjects (matched on age and sex) in order to define a microbial signature specific to the ScS.
Secondary objectives are to study the stability over time of the identified microbial signatures, and to determine a correlation between the composition of the microbiota obtained in the ScS patient and the severity of his symptoms (diffuse skin disease, pulmonary interstitial disease, digestive disease...)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScS patients | – | Other: stool samplingPatients will provide two stool samples: one collected the day of inclusion and a second, six months later |
| Healthy subjects | – | Other: stool samplingHealthy subjects will provide one stool sample at inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ScS according to ACR criteria,and healthy volunteers without diagnosis of ScS or any other chronic disease
Key inclusion criteria (8 listed)
- Patients with ScS according to ACR criteria.
- Patients over 18 years old.
- Patients who have signed the consent to participate in this study.
- Persons without diagnosis of ScS or any other chronic disease.
- Persons over 18 years old.
Key exclusion criteria (8 listed)
- 1. Persons with severe anemia (Hb < 7 g/dL). 2. Persons who cannot read French. 3. For control subjects: Persons with a particular symptom (as an example of digestive disorders), or under long-term treatment related to another pathology.
- 4. Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
- Pregnant, women in labour and breastfeeding mothers.
- Persons deprived of their liberty by a judicial or administrative decision.
- Persons undergoing psychiatric follow-up.
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 samplingParticipants will provide two stool samples: one collected the day of inclusion and a second, six months later | Other | Healthy subjects, ScS patients |
Primary outcome
Differences on gut microbiota composition (bacterial populations) of ScS overtime, at different taxonomic levels (from phyla to species if technique allows) versus healthy controls.
Time frame: 7 months
The patient participation at the study will last 7 months, but healthy volunteers will provide stool sample only once at study entry and won't be followed after that.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Chloé STAVRIS, MD 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?
An observational study of Systemic Sclerosis, 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eya TOUMI, PhD student (04 13 42 81 50, e.toumi@alphabio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences on gut microbiota composition (bacterial populations) of ScS overtime, at different taxonomic levels (from phyla to species if technique allows) versus healthy controls. (time frame: 7 months). 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 25 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.