Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Systemic Sclerosis Clinical Trial

Official title:

A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01804959
• Other study ID #: AL-SScGI
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Dietary Supplement:
• Vivomixx probiotics

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.		After 60 days of either placebo treatment or active drug treatment
Secondary	mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.		After 120 days of placebo treatment or active drug treatment