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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01804959
Other study ID # AL-SScGI
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 2013
Est. completion date December 2020

Study information

Verified date September 2018
Source Singapore General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 2020
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Dietary Supplement:
Vivomixx probiotics


Locations

Country Name City State
Singapore Singapore General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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