Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01804959

Enrollment

Registered

2013-03-05

Start date

2013-05-31

Completion date

2020-12-31

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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.

Interventions

DIETARY_SUPPLEMENTVivomixx probiotics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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.	After 120 days of placebo treatment or active drug treatment

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026