Clinical trial NCT01804959: Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Official title: A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Systemic Sclerosis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.
timeFrame: After 60 days of either placebo treatment or active drug treatment
Secondary outcomes:
measure: mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.
timeFrame: After 120 days of placebo treatment or active drug treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
citation: Low AHL, Teng GG, Pettersson S, de Sessions PF, Ho EXP, Fan Q, Chu CW, Law AHN, Santosa A, Lim AYN, Wang YT, Haaland B, Thumboo J. A double-blind randomized placebo-controlled trial of probiotics in systemic sclerosis associated gastrointestinal disease. Semin Arthritis Rheum. 2019 Dec;49(3):411-419. doi: 10.1016/j.semarthrit.2019.05.006. Epub 2019 May 23.