Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 10:36 PM
Study NCT ID:
NCT01804959
Status:
UNKNOWN
Last Update Posted:
2018-09-10
First Post:
2013-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Sponsor:
Singapore General Hospital
Organization:
Study Overview
Official Title:
A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: