Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis
Status:
Completed
Trial end date:
2019-07-26
Target enrollment:
Participant gender:
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.