Rectal CancerNCT02751736
The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer
A study testing CJLP243 in people with Rectal Cancer, run by Seoul National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- CJLP243
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-75
- with rectal cancer
- s/p low anterior resection (double stapled anastomosis)
Who cannot join
- Metastatic cancer
- Pregnancy
- Valvular heart disease
- s/p intersphincteric resection (index surgery)
- h/o anastomotic leakage (index surgery)
- medically unfit (cardiopulmonary dysfunction, sepsis etc)
About this study
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
The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.
- Conditions
- Rectal Cancer
- Being tested
- CJLP243, Placebo
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJLP243Dietary supplement
Perioperative administration till postoperative weeks 3
PlaceboDietary supplement
Perioperative administration till postoperative weeks 3
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | * 2 g sachet (CJLP 243) once a day for 3 weeks
* 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous) Receives: Dietary Supplement: CJLP243 |
| Control | Placebo comparator | * 2g sachet (near identically appearing placebo) once day for 3 weeks
* maltodextrin, glucose(anhydrous) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memorial Sloan Kettering Cancer Center bowel function index
Subscale: frequency score
Measured: Postoperative weeks 3
Low Anterior Resection Syndrome score
Measured: Postoperative weeks 3
Secondary outcomes (6)
Memorial Sloan Kettering Cancer Center bowel function index
Measured: Postoperative week 1
Low Anterior Resection Syndrome score
Measured: Postoperative week 1
Change of bowel functions index
Measured: Between postoperative week 1 to 3
EORTC C30
Measured: Postoperative week 1 and 3
EORTC CR (Colorectal) 29
Measured: Postoperative week 1 and 3
Postoperative complication
Measured: till Postoperative weeks 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Principal investigator, Heung-Kwon Oh, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751736
- Sponsor's protocol ID
- B-1603-339-003
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02751736
- Acronym / sponsor ID
- B-1603-339-003
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: CJLP243* 2 g sachet (CJLP 243) once a day for 3 weeks * 10 billion lactic acid bacteria(lactobacillus plantarum CJLP243), maltodextrin, glucose(anhydrous) |
| Control | Placebo comparator | Dietary Supplement: Placebo* 2g sachet (near identically appearing placebo) once day for 3 weeks * maltodextrin, glucose(anhydrous) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20-75
- with rectal cancer
- s/p low anterior resection (double stapled anastomosis)
Key exclusion criteria (6 listed)
- Metastatic cancer
- Pregnancy
- Valvular heart disease
- s/p intersphincteric resection (index surgery)
- h/o anastomotic leakage (index surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJLP243Perioperative administration till postoperative weeks 3 | Dietary supplement | Intervention |
| PlaceboPerioperative administration till postoperative weeks 3 | Dietary supplement | Control |
Primary outcome
Memorial Sloan Kettering Cancer Center bowel function index
Time frame: Postoperative weeks 3
Subscale: frequency score
Low Anterior Resection Syndrome score
Time frame: Postoperative weeks 3
6 secondary outcomes
Memorial Sloan Kettering Cancer Center bowel function index
Time frame: Postoperative week 1
Low Anterior Resection Syndrome score
Time frame: Postoperative week 1
Change of bowel functions index
Time frame: Between postoperative week 1 to 3
EORTC C30
Time frame: Postoperative week 1 and 3
EORTC CR (Colorectal) 29
Time frame: Postoperative week 1 and 3
Postoperative complication
Time frame: till Postoperative weeks 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CJLP243 in people with Rectal Cancer, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memorial Sloan Kettering Cancer Center bowel function index (time frame: Postoperative weeks 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.