Probiotics and Recovery From Gastrointestinal Surgery - 2

Surgical Recovery Clinical Trial

— PROGRESS-2  

Official title:

Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04266106
• Other study ID #: MMC-2019-56
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2020
• Est. completion date: October 2021

Study information

• Verified date: February 2020
• Source: MercyOne Des Moines Medical Center
• Contact: Jan Franko
• Phone: 5152473266
• Email: jfranko[@]mercydesmoines.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged =18 years undergoing elective major abdominal operation

• Functional GI tract expected after operation

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Surgical Recovery

Intervention

Drug:
• SuperBio probiotic
One capsule po BID for 28 days
• Placebo
One capsule po BID for 28 days

Locations

Country	Name	City	State
United States	MercyOne Des Moines Medical Center	Des Moines	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Jan Franko, MD	SuperBio

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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