NCT02751736

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

April 7, 2016

Last Update Submit

April 24, 2017

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Memorial Sloan Kettering Cancer Center bowel function index

    Subscale: frequency score

    Postoperative weeks 3

  • Low Anterior Resection Syndrome score

    Postoperative weeks 3

Secondary Outcomes (6)

  • Memorial Sloan Kettering Cancer Center bowel function index

    Postoperative week 1

  • Low Anterior Resection Syndrome score

    Postoperative week 1

  • Change of bowel functions index

    Between postoperative week 1 to 3

  • EORTC C30

    Postoperative week 1 and 3

  • EORTC CR (Colorectal) 29

    Postoperative week 1 and 3

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

* 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

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

CJLP243DIETARY_SUPPLEMENT

Perioperative administration till postoperative weeks 3

Intervention
PlaceboDIETARY_SUPPLEMENT

Perioperative administration till postoperative weeks 3

Control

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share