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

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
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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
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Other: Placebo
Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks |
- 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 ]
- 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 ]

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

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
Contact: Thais Marighela | 55-11-55764239 | thais_fm@hotmail.com |
Brazil | |
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo | |
São Paulo, SP, Brazil |
Principal Investigator: | Cristiane Kayser | Associate Professor |
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 |
Probiotics Immune system |
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Pathologic Processes Connective Tissue Diseases Skin Diseases |