Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

NCT01804959 | Unknown Phase 2 DMC

• 1 other identifier: AL-SScGI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Active vs Placebo

PLACEBO COMPARATOR

In phase I, subjects will be randomized into either the Vivomixx probiotics or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotics (4 sachets/ day or 1800 billion bacteria/day) or placebo (4 placebo sachets/day) for the first 60 days.

Dietary Supplement: Vivomixx probiotics

60 days of Active vs 120 days of Active

ACTIVE COMPARATOR

In phase II, subjects from both arms in phase I will receive Vivomixx probiotics 4 sachets/ day for another 60 days. Comparison will be made between the arm receiving 60 days of Vivomixx probiotics vs 120 days of Vivomixx probiotics

Dietary Supplement: Vivomixx probiotics

Interventions

Vivomixx probiotics DIETARY_SUPPLEMENT

60 days of Active vs 120 days of Active; Active vs Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

Related Publications (1)

• 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.

  PMID: 31208714 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2013
• First Posted: March 5, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2020
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

SG (1)