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

• Status: Completed
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Social security beneficiaries affiliated to the "LA RAZA" UMAE HECMN

• Adults over 18 years old

• Male or female subjects

• Diagnosed with scleroderma (2013 ACR-EULAR)

• Score above the 25th percentile in NIH-PROMIS questionnaire

• Positive result (> 10 ppm) in the hydrogen breath test

• Normal leukocyte and lymphocyte profiles

• Patients who accept to participate in the study by signing the informed consent form

Exclusion Criteria:

• Gastrointestinal diseases already diagnosed and not associated to systemic sclerosis

• Comorbidities associated to visceral diseases (diabetes, amyloidosis or other infiltrative diseases)

• Currently under biological treatment (or history of biological treatment in the last year) with cyclophosphamide and > 10 mg prednisone or equivalent

• Allergy or contra-indications to metronidazole or to Saccharomyces boulardii,

• Central venous catheter carriers