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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Scleroderma Other: Probiotic Other: Placebo Phase 3

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 (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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Other: Probiotic
Probiotic 1g once a day by mouth for 8 weeks
Other Name: Lacto Pro
Placebo Comparator: Placebo
Maltodextrin 1g per sachet, once/day
 Other: Placebo
Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Scleroderma Health Assessment Questionnaire (sHAQ) [ Time Frame: baseline and eight weeks ]
  2. Food intake record [ Time Frame: baseline and eight weeks ]
  3. Anthropometry assessment as measured by the body mass index (BMI) [ Time Frame: baseline and eight weeks ]
  4. C-reactive protein (CRP) and immunoglobulin A (IgA) serum levels [ Time Frame: baseline and eight weeks ]
  5. Proportion of CD4+ and CD8+ T cells [ Time Frame: baseline and eight weeks ]
  6. Tregs (CD4+CD25+Foxp3+CD127low) levels [ Time Frame: baseline and eight weeks ]
  7. Th1, Th2 and Th17 CD4+ T cell subsets levels [ Time Frame: baseline and eight weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302352


Contacts
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Contact: Thais Marighela 55-11-55764239 thais_fm@hotmail.com

Locations
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Brazil
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Cristiane Kayser Associate Professor
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cristiane Kayser, MD, PhD, Associate Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02302352    
Other Study ID Numbers: 2013/26788-3
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: November 27, 2014
Last Verified: November 2014
Keywords provided by Cristiane Kayser, Federal University of São Paulo:
Probiotics
Immune system
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Connective Tissue Diseases
Skin Diseases