Status:
UNKNOWN
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Systemic Sclerosis
Scleroderma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Systemic sclerosis (SSc) is an autoimmune disease with unknown etiology, which affects especially the gastrointestinal tract, lungs, heart and kidneys. Immunological abnormalities characterized by inn...
Detailed Description
Systemic sclerosis (SSc) is a chronic autoimmune disease, which affects the gastrointestinal tract, lungs, heart and kidneys. A shift in the balance between T helper 1 (Th1) and Th2 subtypes and betwe...
Eligibility Criteria
Inclusion
- Patients with systemic sclerosis according to the 2013 ACR/EULAR classification criteria for SSc;
- Patients with gastrointestinal symptoms related to SSc including: gastrointestinal reflux, bloating, diarrhea and constipation;
- Written informed consent provided by the subjects.
Exclusion
- Overlap syndromes with systemic lupus erythematosus, polymyositis/dermatomyositis and rheumatoid arthritis;
- Use of antibiotics and/or probiotics four weeks before baseline;
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02302352
Start Date
December 1 2014
End Date
January 1 2016
Last Update
November 27 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
São Paulo, São Paulo, Brazil