Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Phase 2

• Conditions: Systemic Sclerosis
• Interventions: Dietary Supplement: Vivomixx probiotics

• Registration Number: NCT01804959
• Lead Sponsor: Singapore General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-03
• Study First Submitted QC: 2013-03-03
• Study First Posted: 2013-03-05
• Study Start: 2013-05
• Primary Completion: 2017-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• SSc that fulfills the American College of Rheumatology (ACR, 1990) classification criteria or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis.
• SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases)
• SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10
• Stable doses of immunosuppressive treatment, corticosteroids, and GI medications for 30 days.

Exclusion Criteria

• On anti-biotics or probiotics within the last 30 days
• Current serious infections requiring hospitalization
• Long-term indwelling catheter, including patients on total parenteral nutrition
• Females who are lactating or pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active vs Placebo	Vivomixx probiotics	In phase I, subjects will be randomized into either the Vivomixx probiotics or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotics (4 sachets/ day or 1800 billion bacteria/day) or placebo (4 placebo sachets/day) for the first 60 days.
60 days of Active vs 120 days of Active	Vivomixx probiotics	In phase II, subjects from both arms in phase I will receive Vivomixx probiotics 4 sachets/ day for another 60 days. Comparison will be made between the arm receiving 60 days of Vivomixx probiotics vs 120 days of Vivomixx probiotics

Primary Outcome Measures

Name	Time	Method
mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.	After 60 days of either placebo treatment or active drug treatment

Secondary Outcome Measures

Name	Time	Method
mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.	After 120 days of placebo treatment or active drug treatment

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore