Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients
ConditionSystemic Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital Européen Marseille
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Pregnant, women in labour and breastfeeding mothers.
Persons deprived of their liberty by a judicial or administrative decision.
Persons undergoing psychiatric follow-up.
Trial population
Patients with ScS according to ACR criteria,and healthy volunteers without diagnosis of ScS or any other chronic disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
stool sampling
Other interventionParticipants will provide two stool samples: one collected the day of inclusion and a second, six months later
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ScS patients1 intervention
Group B: Healthy subjects1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
7 monthsSponsors and contacts
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Source ClinicalTrials.gov