Probiotics and Recovery From Gastrointestinal Surgery – 2

Overview

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.

Full Title of Study: “Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings – 2″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2021

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo Comparator
  • Experimental: probiotic

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life
    • Time Frame: up to 2 months
    • Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jan Franko, MD
  • Collaborator
    • SuperBio
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jan Franko, MD, Chair of Surgical Oncology – MercyOne Des Moines Medical Center
  • Overall Official(s)
    • Jan Franko, Principal Investigator, MercyOne Des Moines Medical Center
  • Overall Contact(s)
    • Jan Franko, 5152473266, jfranko@mercydesmoines.org

References

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.

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