Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Dietary Supplement: Vivomixx probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Active vs Placebo<br>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. | Dietary Supplement: Vivomixx probiotics<br> <br> |
| Active Comparator: 60 days of Active vs 120 days of Active<br>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 | Dietary Supplement: Vivomixx probiotics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |