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

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.

Study Overview

• Status: Unknown
• Conditions: Surgical Recovery
• Intervention / Treatment: Drug: Placebo; Drug: SuperBio probiotic

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • MercyOne Des Moines Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Drug: Placebo; One capsule po BID for 28 days
Experimental: probiotic	Drug: SuperBio probiotic; One capsule po BID for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jan Franko, MD
• Collaborators: SuperBio
• Investigators: Principal Investigator: Jan Franko, MercyOne Des Moines Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MMC-2019-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes