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

NCT ID: NCT02302352

Last Updated: 2014-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Systemic Sclerosis Scleroderma

Keywords

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Probiotics Immune system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type OTHER

Probiotic 1g once a day by mouth for 8 weeks

Placebo

Maltodextrin 1g per sachet, once/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks

Interventions

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Probiotic

Probiotic 1g once a day by mouth for 8 weeks

Intervention Type OTHER

Placebo

Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks

Intervention Type OTHER

Other Intervention Names

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Lacto Pro

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Cristiane Kayser

MD, PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristiane Kayser

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Thais Marighela

Role: CONTACT

Phone: 55-11-55764239

Email: [email protected]

References

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Marighela TF, Arismendi MI, Marvulle V, Brunialti MKC, Salomao R, Kayser C. Effect of probiotics on gastrointestinal symptoms and immune parameters in systemic sclerosis: a randomized placebo-controlled trial. Rheumatology (Oxford). 2019 Nov 1;58(11):1985-1990. doi: 10.1093/rheumatology/kez160.

Reference Type DERIVED
PMID: 31056685 (View on PubMed)

Other Identifiers

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2013/26788-3

Identifier Type: -

Identifier Source: org_study_id