NCT02302352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 27, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

November 17, 2014

Last Update Submit

November 24, 2014

Conditions

Systemic SclerosisScleroderma

Keywords

ProbioticsImmune system

Outcome Measures

Primary Outcomes (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

    baseline and eight weeks

Secondary Outcomes (7)

  • Scleroderma Health Assessment Questionnaire (sHAQ)

    baseline and eight weeks

  • Food intake record

    baseline and eight weeks

  • Anthropometry assessment as measured by the body mass index (BMI)

    baseline and eight weeks

  • C-reactive protein (CRP) and immunoglobulin A (IgA) serum levels

    baseline and eight weeks

  • Proportion of CD4+ and CD8+ T cells

    baseline and eight weeks

  • +2 more secondary outcomes

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Maltodextrin 1g per sachet, once/day

Other: Placebo

Interventions

ProbioticOTHER

Probiotic 1g once a day by mouth for 8 weeks

Also known as: Lacto Pro
Probiotic
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Overlap syndromes with systemic lupus erythematosus, polymyositis/dermatomyositis and rheumatoid arthritis;
  • Use of antibiotics and/or probiotics four weeks before baseline;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31056685DERIVED

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cristiane Kayser

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thais Marighela

CONTACT

55-11-55764239thais_fm@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 27, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

January 1, 2016

Last Updated

November 27, 2014

Record last verified: 2014-11

Locations

BR(1)