Probiotics and Recovery From Surgery

NCT ID: NCT01970683

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-02-28

Brief Summary

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The study will investigate whether probiotics given just before and shortly after major abdominal operation improve outcomes.

Detailed Description

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Perioperative probiotic intervention is associated with approximately 30% reduction of primary outcome measure.

Conditions

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Major Abdominal Operation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VSL #3

probiotics given orally BID

Group Type EXPERIMENTAL

VSL #3 BID

Intervention Type DIETARY_SUPPLEMENT

placebo

Near-identically appearing placebo

Group Type OTHER

VSL #3 BID

Intervention Type DIETARY_SUPPLEMENT

Interventions

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VSL #3 BID

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* All elective major GI surgical patients

Exclusion Criteria

* • Current episode of acute pancreatitis as defined by clinician

* Active medication-induced immunosuppression including systemic corticosteroids, chemotherapy within 4 weeks, immunomodulating agents with transplant indication, biologicals for rheumatoid arthritis and inflammatory bowel disease. Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic Health Initiatives

OTHER

Sponsor Role lead

Responsible Party

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Jan Franko

Surgical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mercy Medical Center-Des Moines

Des Moines, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31562911 (View on PubMed)

Other Identifiers

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MMC-2013-132

Identifier Type: -

Identifier Source: org_study_id

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