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Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

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ClinicalTrials.gov Identifier: NCT01804959
Recruitment Status : Active, not recruiting
First Posted : March 5, 2013
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Dietary Supplement: Vivomixx probiotics Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Study Start Date : May 2013
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Active vs Placebo
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
Active Comparator: 60 days of Active vs 120 days of Active
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804959


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169856
Sponsors and Collaborators
Singapore General Hospital

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01804959     History of Changes
Other Study ID Numbers: AL-SScGI
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Connective Tissue Diseases
Skin Diseases