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

NCT ID: NCT02751736

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

CJLP243

Intervention Type DIETARY_SUPPLEMENT

Perioperative administration till postoperative weeks 3

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Perioperative administration till postoperative weeks 3

Interventions

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CJLP243

Perioperative administration till postoperative weeks 3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Perioperative administration till postoperative weeks 3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heung-Kwon Oh

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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B-1603-339-003

Identifier Type: -

Identifier Source: org_study_id

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