NCT01804959

Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vivomixx probiotics

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-11-01
• Completion: 2020-12-01
• First posted: 2013-03-05
• Last updated: 2018-09-10

Locations

1 site across 1 country: Singapore