Ignite Creation Date:
2024-05-06 @ 3:30 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02302352
Status:
UNKNOWN
Last Update Posted:
2014-11-27
First Post:
2014-11-17
Brief Title:
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis a Randomized Double-blind Placebo-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSc
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 innate and acquired immune disturbances are associated with the disease development The present study aims to evaluate the efficacy and safety of probiotics in gastrointestinal symptoms nutritional status and innate and acquired immune responses by means of the evaluation of IgA Treg and Th1 Th2 and Th17 T helper subtypes levels in patients with SSc In addition the levels of CD4 T helper Th1 Th2 and Th17 subtypes and Treg levels will be compared to a healthy control group
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 between regulatory T cells Treg and Th17 cells levels as well as intestinal microbiota abnormalities may be present in SSc These abnormalities can stimulate inflammatory response and cause intestinal epithelial damage The use of oral probiotics for microbiome or immune response modulation can be attractive especially in autoimmune diseases Objectives To evaluate the efficacy and safety of probiotics in gastrointestinal symptoms nutritional status and innate and acquired immune responses by means of the evaluation of IgA Treg and Th1 Th2 and Th17 T helper subtypes levels in patients with SSc In addition the levels of CD4 T helper Th1 Th2 and Th17 subtypes and Treg levels will be compared to a healthy control group Patients and methods A randomized double-blind placebo-controlled clinical trial with 76 SSc patients will be performed Patients will be randomly assigned to receive oral probiotics once a day or placebo for 8 weeks The primary outcome will be changes in the gastrointestinal symptoms between baseline and week 8 Clinical evaluation scleroderma Health Assessment Questionnaire sHAQ food intake record anthropometry assessment and laboratory evaluation will be performed at baseline T0 at week 4 T1 and week 8 T2 C-reactive protein CRP and immunoglobulin A IgA serum levels assessment will be performed at each visit The proportion of CD4 and CD8 T cells and Tregs CD4CD25Foxp3CD127low and Th1 Th2 e Th17 CD4 T cell subsets levels will be evaluated using flow cytometer at each visit in SSc patients and also in 50 healthy subjetcs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None