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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT01497743 |
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Date of registration:
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20/12/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
PRISS |
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Scientific title:
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Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01497743 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult patient =18 years.
2. Patients with SSc with moderate-to-severe distention/bloating on GIT 2. scale (scale
score >1.00).
3. Stable immunosuppressive therapy(ies) for = 1 month.
4. Stable PPI and/or other anti-reflux medications for = 1 month.
5. Stable calcium channel blocker for = 1 month.
6. Stable NSAID for = 1 month.
7. Stable dose of pro-motility agent for = 1 month.
Exclusion criteria:
1. Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1
month.
2. Treatment with antibiotics within last 2 weeks.
3. Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on
methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine.
4. Severe diarrhea (Diarrhea scale score of = 1.01; may suggest untreated SIBO).
5. History of inherited or acquired immunodeficiency
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scleroderma
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Intervention(s)
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Drug: Lactobacillus
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Primary Outcome(s)
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1. Proportion of patients with improvement in distention/bloating scale = 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)
[Time Frame: 12 months]
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Secondary ID(s)
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KhannaSN0000
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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