Status:
WITHDRAWN
Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Lead Sponsor:
University of Michigan
Conditions:
Scleroderma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely debilitating and even l...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult patient ≥18 years.
- Patients with SSc with moderate-to-severe distention/bloating on GIT 2. scale (scale score \>1.00).
- Stable immunosuppressive therapy(ies) for ≥ 1 month.
- Stable PPI and/or other anti-reflux medications for ≥ 1 month.
- Stable calcium channel blocker for ≥ 1 month.
- Stable NSAID for ≥ 1 month.
- Stable dose of pro-motility agent for ≥ 1 month.
- Exclusion criteria:
- Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1 month.
- Treatment with antibiotics within last 2 weeks.
- Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine.
- Severe diarrhea (Diarrhea scale score of ≥ 1.01; may suggest untreated SIBO).
- History of inherited or acquired immunodeficiency
- \-
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01497743
Start Date
February 1 2012
Last Update
December 22 2016
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