Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Singapore General Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Systemic Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.

Time frame: After 60 days of either placebo treatment or active drug treatment

Secondary Outcomes

mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.

Time frame: After 120 days of placebo treatment or active drug treatment