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

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ClinicalTrials.gov Identifier: NCT02751736
Recruitment Status : Unknown
Verified April 2017 by Heung-Kwon Oh, Seoul National University Bundang Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by (Responsible Party):
Heung-Kwon Oh, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Dietary Supplement: CJLP243 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Intervention
  • 2 g sachet (CJLP 243) once a day for 3 weeks
  • 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous)
Dietary Supplement: CJLP243
Perioperative administration till postoperative weeks 3

Placebo Comparator: Control
  • 2g sachet (near identically appearing placebo) once day for 3 weeks
  • maltodextrin, glucose(anhydrous)
Dietary Supplement: Placebo
Perioperative administration till postoperative weeks 3




Primary Outcome Measures :
  1. Memorial Sloan Kettering Cancer Center bowel function index [ Time Frame: Postoperative weeks 3 ]
    Subscale: frequency score

  2. Low Anterior Resection Syndrome score [ Time Frame: Postoperative weeks 3 ]

Secondary Outcome Measures :
  1. Memorial Sloan Kettering Cancer Center bowel function index [ Time Frame: Postoperative week 1 ]
  2. Low Anterior Resection Syndrome score [ Time Frame: Postoperative week 1 ]
  3. Change of bowel functions index [ Time Frame: Between postoperative week 1 to 3 ]
  4. EORTC C30 [ Time Frame: Postoperative week 1 and 3 ]
  5. EORTC CR (Colorectal) 29 [ Time Frame: Postoperative week 1 and 3 ]
  6. Postoperative complication [ Time Frame: till Postoperative weeks 3 ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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Responsible Party: Heung-Kwon Oh, Clinical Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02751736     History of Changes
Other Study ID Numbers: B-1603-339-003
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases