Probiotics and Recovery From Gastrointestinal Surgery - 2

Last updated: February 11, 2020
Sponsor: Jan Franko, MD
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04266106
MMC-2019-56
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged ≥18 years undergoing elective major abdominal operation

  • Functional GI tract expected after operation

Exclusion

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, includingrheumatoid arthritis, SLE, scleroderma, etc.

  • Topical chemotherapy or corticosteroids, and chemotherapy applied during operation areallowed

  • Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle

  • Need for full systemic anticoagulation postoperatively.

Study Design

Total Participants: 300
Study Start date:
February 01, 2020
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • MercyOne Des Moines Medical Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

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