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Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis (SSc)

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ClinicalTrials.gov Identifier: NCT02302352
Recruitment Status : Unknown
Verified November 2014 by Cristiane Kayser, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2014
Last Update Posted : November 27, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Cristiane Kayser, Federal University of São Paulo

November 17, 2014
November 27, 2014
November 27, 2014
December 2014
April 2015   (Final data collection date for primary outcome measure)
Changes in the gastrointestinal symptoms as measured by the "The University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (GIT 2.0)" Questionnaire [ Time Frame: baseline and eight weeks ]
Same as current
No Changes Posted
  • Scleroderma Health Assessment Questionnaire (sHAQ) [ Time Frame: baseline and eight weeks ]
  • Food intake record [ Time Frame: baseline and eight weeks ]
  • Anthropometry assessment as measured by the body mass index (BMI) [ Time Frame: baseline and eight weeks ]
  • C-reactive protein (CRP) and immunoglobulin A (IgA) serum levels [ Time Frame: baseline and eight weeks ]
  • Proportion of CD4+ and CD8+ T cells [ Time Frame: baseline and eight weeks ]
  • Tregs (CD4+CD25+Foxp3+CD127low) levels [ Time Frame: baseline and eight weeks ]
  • Th1, Th2 and Th17 CD4+ T cell subsets levels [ Time Frame: baseline and eight weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis
Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis: a Randomized Double-blind Placebo-controlled Clinical Trial
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.
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 (CD4+CD25+Foxp3+CD127low), 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Systemic Sclerosis
  • Scleroderma
  • Other: Probiotic
    Probiotic 1g once a day by mouth for 8 weeks
    Other Name: Lacto Pro
  • Other: Placebo
    Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks
  • Active Comparator: Probiotic
    Oral probiotic 1g, once/day, containing: Lactobacillus paracasei, 10x9 CFU; Lactobacillus rhamnosus,10x9 CFU; Lactobacillus acidophillus, 10x9 CFU; Bifidobacterium lactis 10x9 CFU per sachet
    Intervention: Other: Probiotic
  • Placebo Comparator: Placebo
    Maltodextrin 1g per sachet, once/day
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
76
Same as current
January 2016
April 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Overlap syndromes with systemic lupus erythematosus, polymyositis/dermatomyositis and rheumatoid arthritis;
  • Use of antibiotics and/or probiotics four weeks before baseline;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT02302352
2013/26788-3
No
Not Provided
Not Provided
Cristiane Kayser, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Cristiane Kayser Associate Professor
Federal University of São Paulo
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP