NCT01413659

Brief Summary

The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2011

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

August 8, 2011

Last Update Submit

August 24, 2011

Conditions

Postoperative Wound Infection

Keywords

Colorectal surgerySurgical site infectionSymbiotic

Outcome Measures

Primary Outcomes (1)

  • Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.

    15 months

Secondary Outcomes (1)

  • The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.

    15 months

Study Arms (1)

Symbiotic

EXPERIMENTAL

Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host

Biological: Symbiotic

Interventions

SymbioticBIOLOGICAL

Oral symbiotic every 8 h since 2 days before operation; Symbiotic resumes postoperatively on day +2 until day +4 for a total of 4 d of treatment (12 doses).

Symbiotic

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • More than 14 years old
  • Candidate for elective colorectal surgery

You may not qualify if:

  • Denied written informed consent,
  • Severe neutropenia, and
  • Critically ill condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 10, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

August 25, 2011

Record last verified: 2011-07