Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Systemic Sclerosis
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 o...

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...)

Tracking Information

NCT #
NCT04132206
Collaborators
Not Provided
Investigators
Principal Investigator: Chloé STAVRIS, MD Hôpital Européen Marseille