Probiotics and Recovery From Gastrointestinal Surgery - 2 | NCT04266106

Studies
Probiotics and Recovery From Gastrointestinal Surgery - 2

NCT04266106

Sponsor

Jan Franko, MD

Status

Unknown status

Last Update Posted

Feb 13, 2020Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Surgical Recovery

Interventions

SuperBio probiotic
Placebo

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2020Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 11, 2020

First Posted Date

Feb 12, 2020Actual

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

Feb 11, 2020

Last Update Posted Date

Feb 13, 2020Actual

Name	Class
SuperBio	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Comparator	Placebo Comparator		Drug: Placebo
probiotic	Experimental		Drug: SuperBio probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SuperBio probiotic	Drug	One capsule po BID for 28 days	probiotic
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Franko	Contact	5152473266		jfranko@mercydesmoines.org

Overall Officials

Name	Affiliation	Role
Jan Franko	MercyOne Des Moines Medical Center	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31562911	Background	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.