Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

September 6, 2018 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169856
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 60 days of either placebo treatment or active drug treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
After 120 days of placebo treatment or active drug treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 3, 2013

First Submitted That Met QC Criteria

March 3, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL-SScGI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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