Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Sponsor

Singapore General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01804959

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Dietary Supplement: Vivomixx probiotics	Phase 2

Study Design

Study Type:

Interventional

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 1, 2013

Actual Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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. [After 120 days of placebo treatment or active drug treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore General Hospital	Singapore		Singapore	169856

Sponsors and Collaborators

Singapore General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Singapore General Hospital

ClinicalTrials.gov Identifier:

NCT01804959

Other Study ID Numbers:

AL-SScGI

First Posted:

Mar 5, 2013

Last Update Posted:

Sep 10, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Gastrointestinal Diseases

Digestive System Diseases

Scleroderma, Systemic

Scleroderma, Diffuse

Sclerosis

Study Results

No Results Posted as of Sep 10, 2018