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NCT02751736 Clinical Trial

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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02751736
Other study ID # B-1603-339-003
Secondary ID
Status Enrolling by invitation
Phase N/A
First received April 7, 2016
Last updated April 24, 2017
Start date April 2016
Est. completion date December 2017

Study information
Verified date April 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• CJLP243
Perioperative administration till postoperative weeks 3
• Placebo
Perioperative administration till postoperative weeks 3

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital CJ HealthCare Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Memorial Sloan Kettering Cancer Center bowel function index Subscale: frequency score Postoperative weeks 3
Primary Low Anterior Resection Syndrome score Postoperative weeks 3
Secondary Memorial Sloan Kettering Cancer Center bowel function index Postoperative week 1
Secondary Low Anterior Resection Syndrome score Postoperative week 1
Secondary Change of bowel functions index Between postoperative week 1 to 3
Secondary EORTC C30 Postoperative week 1 and 3
Secondary EORTC CR (Colorectal) 29 Postoperative week 1 and 3
Secondary Postoperative complication till Postoperative weeks 3
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