Sigmoid Colon CancerNCT03531606
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
A study testing Mechnicov probiotics in people with Sigmoid Colon Cancer, run by Kye Bong-Hyeon at 1 site in South Korea.
Trial summary
The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sigmoid Colon Cancer
- What is being tested?
- Mechnicov probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2016to 30 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female aged 20 to over 75 years old
- As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
- Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.
Who cannot join
- Those who have metastatic colorectal cancer screening
- Those who have urinary incontinence or fecal incontinence
- Those who received preoperative chemotherapy or radiotherapy
- Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
- Those who have neurologist or psychologically important psychiatric history or current disease
- Those who have alcohol addiction, substance abuse
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- Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
- Those who have uncontrolled hypertension, diabetes patients
- Those who have creatinine with more than twice from normal upper limit in site
- Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
- Those who have probiotics, antibiotics, continually within the last one week
- Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
- Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
- under the investigator's judgment, those who is not qualified to participate this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.
Read the detailed description
The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.
- Conditions
- Sigmoid Colon Cancer
- Being tested
- Mechnicov probiotics, Placebo
- Medical subject headings
- Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechnicov probioticsDrug
Also called Anterior resection
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
PlaceboDrug
Also called Anterior resection
Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' Receives: Drug: Mechnicov probiotics |
| Placebo comparator | Placebo comparator | Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior resection syndrome improvement change
3 times performed through questionnaire
Measured: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
Secondary outcomes (7)
Bowel examination
2 times performed through questionnaire
Measured: 4 weeks after surgery, 5 weeks after surgery
Quality of Life of Cancer Patients(EORTC QLQ-C30)
2 times performed through questionnaire
Measured: 1 week before surgery, 4 weeks after surgery
Markers related Inflammation
WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio
Measured: 1 week before surgery, 4 weeks after surgery
NSI(Nutritional Screening Index)
PG-SGA: Patient-Generated Subjective Global Assessment
Measured: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Clavien-Dindo Classification
Assessment through "Clavien-Dindo Classification"
Measured: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
NGS, SCFA
NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid)
Measured: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery
Other biomarkers
Zonulin, other Cytokines
Measured: 1 week before surgery, 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start12 Dec 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid Colon CancerStudies of the same condition, open and under way.
- 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
- Model description
- This study has been designed for randomized, double Blinded, placebo clinical trial.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kye Bong-Hyeon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kye Bong-Hyeon, The Catholic University of Korea
- Investigators
- SungSik Jang, Ph.D, Study director, R &D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531606
- Sponsor's protocol ID
- KY_Mpro3
- Status last verified
- Jul 2018
- First submitted
- 15 Apr 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03531606
- Acronym / sponsor ID
- KY_Mpro3
- Conditions
- Sigmoid Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kye Bong-HyeonUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 May 2018 (actual)
- 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 purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.
Detailed description
The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study has been designed for randomized, double Blinded, placebo clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Mechnicov probioticsUsing placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' |
| Placebo comparator | Placebo comparator | Drug: PlaceboUsing placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female aged 20 to over 75 years old
- As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
- Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.
Key exclusion criteria (14 listed)
- Those who have metastatic colorectal cancer screening
- Those who have urinary incontinence or fecal incontinence
- Those who received preoperative chemotherapy or radiotherapy
- Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
- Those who have neurologist or psychologically important psychiatric history or current disease
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 |
|---|---|---|
| Mechnicov probioticsAlso: Anterior resectionUsing placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' | Drug | Experimental |
| PlaceboAlso: Anterior resectionUsing placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one. The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery. (1 week before surgery and 3 weeks after surgery) The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer' | Drug | Placebo comparator |
Primary outcome
Anterior resection syndrome improvement change
Time frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery
3 times performed through questionnaire
7 secondary outcomes
Bowel examination
Time frame: 4 weeks after surgery, 5 weeks after surgery
Quality of Life of Cancer Patients(EORTC QLQ-C30)
Time frame: 1 week before surgery, 4 weeks after surgery
Markers related Inflammation
Time frame: 1 week before surgery, 4 weeks after surgery
NSI(Nutritional Screening Index)
Time frame: 1 week before surgery, 1.5 weeks after surgery, 4 weeks after surgery
Clavien-Dindo Classification
Time frame: 1 week after surgery, 1.5 weeks after surgery, 4 weeks after surgery
NGS, SCFA
Time frame: 1 week before surgery, 1 week after surgery, 4 weeks after surgery, 5 weeks after surgery
Other biomarkers
Time frame: 1 week before surgery, 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- 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.
SungSik Jang, Ph.D study director
R &D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechnicov probiotics in people with Sigmoid Colon Cancer, run by Kye Bong-Hyeon at 1 site in South Korea.
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 14 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: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anterior resection syndrome improvement change (time frame: 1 week before surgery, 4 weeks after surgery, 5 weeks after surgery). 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 18 Jul 2018.