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

Seoul National University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: CJLP243

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02751736

B-1603-339-003

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: CJLP243

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo