- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970683
Probiotics and Recovery From Surgery (PROGRESS)
July 23, 2017 updated by: Jan Franko, Catholic Health Initiatives
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings.
The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center-Des Moines
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All elective major GI surgical patients
Exclusion Criteria:
• Current episode of acute pancreatitis as defined by clinician
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VSL #3
probiotics given orally BID
|
|
Other: placebo
Near-identically appearing placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
30-day postsurgical outcome including death, infection, readmission
Time Frame: within 30 days after surgery
|
within 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 28, 2017
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 23, 2013
First Posted (Estimate)
October 28, 2013
Study Record Updates
Last Update Posted (Actual)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 23, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- MMC-2013-132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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