Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Singapore Health Services (SingHealth)

Status and phase: Unknown; Phase 2

Conditions: Systemic Sclerosis

Treatments: Dietary Supplement: Vivomixx probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01804959

AL-SScGI

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Active vs Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Vivomixx probiotics

60 days of Active vs 120 days of Active

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vivomixx probiotics