Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
140 participants
INTERVENTIONAL
2014-08-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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VSL #3
probiotics given orally BID
VSL #3 BID
placebo
Near-identically appearing placebo
VSL #3 BID
Interventions
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VSL #3 BID
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.
18 Years
99 Years
ALL
No
Sponsors
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Catholic Health Initiatives
OTHER
Responsible Party
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Jan Franko
Surgical Oncologist
Locations
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Mercy Medical Center-Des Moines
Des Moines, Iowa, United States
Countries
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References
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Franko J, Raman S, Krishnan N, Frankova D, Tee MC, Brahmbhatt R, Goldman CD, Weigel RJ. Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation. J Am Coll Surg. 2019 Dec;229(6):533-540.e1. doi: 10.1016/j.jamcollsurg.2019.09.002. Epub 2019 Sep 25.
Other Identifiers
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MMC-2013-132
Identifier Type: -
Identifier Source: org_study_id
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