Probiotics and Recovery From Gastrointestinal Surgery - 2
PROGRESS-2
Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2
1 other identifier
interventional
300
1 country
1
Brief Summary
This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 13, 2020
February 1, 2020
1.3 years
February 10, 2020
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life
Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points
up to 2 months
Study Arms (2)
Placebo Comparator
PLACEBO COMPARATORprobiotic
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adults aged ≥18 years undergoing elective major abdominal operation
- Functional GI tract expected after operation
You may not qualify if:
- Current episode of acute necrotizing pancreatitis as defined by surgeon
- Palliative decompressive GI tube
- Life expectancy ≤ 6 months
- Systemic immune-mediated disease active requiring systemic therapy:
- Prednisone ≥20 mg QD
- IV immunoglobulins
- Anti-rejection medication
- Presence of functional transplanted organ
- Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
- Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
- Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
- Need for full systemic anticoagulation postoperatively.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jan Franko, MDlead
- SuperBiocollaborator
Study Sites (1)
MercyOne Des Moines Medical Center
Des Moines, Iowa, 50314, United States
Related Publications (1)
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.
PMID: 31562911BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Franko
MercyOne Des Moines Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair of Surgical Oncology
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 12, 2020
Study Start
February 1, 2020
Primary Completion
June 1, 2021
Study Completion
October 1, 2021
Last Updated
February 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
No sharing