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The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CJLP243
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 20-75
  • with rectal cancer
  • s/p low anterior resection (double stapled anastomosis)

Exclusion Criteria:

  • Metastatic cancer
  • Pregnancy
  • Valvular heart disease
  • s/p intersphincteric resection (index surgery)
  • h/o anastomotic leakage (index surgery)
  • medically unfit (cardiopulmonary dysfunction, sepsis etc)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    2 g sachet (CJLP 243) once a day for 3 weeks 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous)

    2g sachet (near identically appearing placebo) once day for 3 weeks maltodextrin, glucose(anhydrous)

    Outcomes

    Primary Outcome Measures

    Memorial Sloan Kettering Cancer Center bowel function index
    Subscale: frequency score
    Low Anterior Resection Syndrome score

    Secondary Outcome Measures

    Memorial Sloan Kettering Cancer Center bowel function index
    Low Anterior Resection Syndrome score
    Change of bowel functions index
    EORTC C30
    EORTC CR (Colorectal) 29
    Postoperative complication

    Full Information

    First Posted
    April 7, 2016
    Last Updated
    April 24, 2017
    Sponsor
    Seoul National University Hospital
    Collaborators
    HK inno.N Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02751736
    Brief Title
    The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer
    Official Title
    The Effect Of Probiotics From Kimchi (CJLP243) On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer: A Pilot Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    HK inno.N Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    2 g sachet (CJLP 243) once a day for 3 weeks 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous)
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    2g sachet (near identically appearing placebo) once day for 3 weeks maltodextrin, glucose(anhydrous)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    CJLP243
    Intervention Description
    Perioperative administration till postoperative weeks 3
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Perioperative administration till postoperative weeks 3
    Primary Outcome Measure Information:
    Title
    Memorial Sloan Kettering Cancer Center bowel function index
    Description
    Subscale: frequency score
    Time Frame
    Postoperative weeks 3
    Title
    Low Anterior Resection Syndrome score
    Time Frame
    Postoperative weeks 3
    Secondary Outcome Measure Information:
    Title
    Memorial Sloan Kettering Cancer Center bowel function index
    Time Frame
    Postoperative week 1
    Title
    Low Anterior Resection Syndrome score
    Time Frame
    Postoperative week 1
    Title
    Change of bowel functions index
    Time Frame
    Between postoperative week 1 to 3
    Title
    EORTC C30
    Time Frame
    Postoperative week 1 and 3
    Title
    EORTC CR (Colorectal) 29
    Time Frame
    Postoperative week 1 and 3
    Title
    Postoperative complication
    Time Frame
    till Postoperative weeks 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 20-75 with rectal cancer s/p low anterior resection (double stapled anastomosis) Exclusion Criteria: Metastatic cancer Pregnancy Valvular heart disease s/p intersphincteric resection (index surgery) h/o anastomotic leakage (index surgery) medically unfit (cardiopulmonary dysfunction, sepsis etc)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer

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