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Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis

NCT03692299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-07-30

No results posted yet for this study

Summary

Introduction. Autonomic dysfunction, smooth muscle fibrosis and vascular damage lead to small intestinal bacterial overgrowth (SIBO) in Systemic Sclerosis (SSc). SIBO is characterized by diarrhea, abdominal pain, bloating, malabsorption and malnutrition.

Aim. To evaluate the efficacy and safety of Saccharomyces boulardii in combination with metronidazole for 2 months for reducing gastrointestinal symptoms (NIH-PROMIS) and preventing bacterial overgrowth (hydrogen breath test) versus the standard treatment in patients with systemic sclerosis.

Method. Controlled clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. NIH PROMIS®questionarie will be apply to evaluate gastrointestinal symptoms and classify in not symptomatic, least, mildy, moderately and most symptomatic. Glucose HBT will be apply after 14 hours fast, oral hygiene and 30 days free of antibiotics to evaluate SIBO. Patients with negative HBT and symptoms associated to glucose ingestion will repeat test with lactulose. Patients will be aleatorized into 1. Saccharomyces boulardii, 2. Metronidazole and 3. Metronidazole plus Saccharomyces boulardii.

All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.

Conditions

Interventions

DRUG

Saccharomyces Boulardii Oral Tablet

Saccharomyces boulardii 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.

DRUG

Metronidazole

Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Maria Pilar Cruz-Domínguez, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-07-26
Completion
2019-07-26

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03692299 on ClinicalTrials.gov