Probiotics and Recovery From Surgery | NCT01970683

Studies
Probiotics and Recovery From Surgery

NCT01970683

Sponsor

Catholic Health Initiatives

Status

Terminated

Last Update Posted

Jul 25, 2017Actual

Enrollment

140Actual

Phase

Phase 3

Conditions

Major Abdominal Operation

Interventions

VSL #3 BID

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

organizational problems

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2017

Last Update Posted Date

Jul 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VSL #3	Experimental	probiotics given orally BID	Dietary Supplement: VSL #3 BID
placebo	Other	Near-identically appearing placebo	Dietary Supplement: VSL #3 BID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSL #3 BID	Dietary Supplement		VSL #3 placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day postsurgical outcome including death, infection, readmission		within 30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mercy Medical Center-Des Moines		Des Moines	Iowa	50314	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31562911	Derived	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.

Type	Date	Date Unknown
Release	Sep 20, 2020
Reset	Oct 14, 2020