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Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Systemic Sclerosis Clinical Trial

Official title:
A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Clinical Trial Summary

SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01804959
Study type Interventional
Source Singapore General Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 2013
Completion date December 2020
View Details
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