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Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Primary Purpose

Systemic Sclerosis

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Vivomixx probiotics
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Active vs Placebo

60 days of Active vs 120 days of Active

Arm Description

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.

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

Outcomes

Primary Outcome Measures

mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.

Secondary Outcome Measures

mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.

Full Information

First Posted
March 3, 2013
Last Updated
September 6, 2018
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01804959
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active vs Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
60 days of Active vs 120 days of Active
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Vivomixx probiotics
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
31208714
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.
Results Reference
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Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

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