Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01804959
• Date of registration: 03/03/2013
• Prospective Registration: Yes
• Primary sponsor: Singapore General Hospital
• Public title: Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
• Scientific title: A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
• Date of first enrolment: May 2013
• Target sample size: 40
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT01804959
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Singapore

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Dietary Supplement: Vivomixx probiotics

Primary Outcome(s)

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 Outcome(s)

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]

Secondary ID(s)

AL-SScGI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors