Status:
UNKNOWN
Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Lead Sponsor:
Singapore General Hospital
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 demon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01804959
Start Date
May 1 2013
End Date
December 1 2020
Last Update
September 10 2018
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169856