Colon NeoplasmsAI-MPRO3NCT07792980
AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients
A study testing MPRO3 in people with Colon Neoplasms, run by hy Co., LTD. at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the effects of MPRO3(probiotics mixture) supplementation on surgical outcomes and gut health in patients undergoing surgery for colon cancer.The main question is whether MPRO3 supplementation before and after surgery can reduce postoperative infectious complications… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Neoplasms
- What is being tested?
- MPRO3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Aug 2026to 12 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person who is diagnosed histologically or radiologically with adenocarcinoma of the colon and is scheduled to undergo surgery
Who cannot join
- A person who has received chemotherapy or radiotherapy for colon cancer before surgery
- A person with fecal incontinence
- A person who has been diagnosed with an acute or serious disease, such as liver, kidney, heart, or thyroid disease, or is taking related medication
- A person with alcohol dependence or a history of drug abuse
- A person with immune system disorders, infectious diseases, or gastrointestinal diseases, including inflammatory bowel disease
- A person who is currently diagnosed with or receiving treatment for another type of cancer
Show all 13Show fewer
- A person with renal dysfunction, defined as serum creatinine at least 1.5 times the upper limit of normal, or liver dysfunction, defined as AST and/or ALT at least 2.5 times the upper limit of normal
- A person who has continuously used probiotics within the previous week
- A person who is pregnant or lactating
- A person who has hypersensitivity to the investigational product or any of its ingredients, or an allergy to a specific ingredient
- A person who has participated in another human study or drug clinical trial within one month before the start of this study, except for a study involving only non-invasive surveys
- A person who is unable to read letters or whose ability is limited
- A person deemed inappropriate by the investigator to participate in this study for other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul ST. Mary's Hospital
Seoul, Seoul
Nayeon Song, +82-10-4365-1088, mind1088@naver.com
Ingyu Lee
About this study
Official title: AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients: A 13-Week, Randomized, Double-Blind, Placebo-Controlled Trial (AI-MPRO3 Study)
The goal of this clinical trial is to evaluate the effects of MPRO3(probiotics mixture) supplementation on surgical outcomes and gut health in patients undergoing surgery for colon cancer.The main question is whether MPRO3 supplementation before and after surgery can reduce postoperative infectious complications compared with placebo.Participants will take either MPRO3 or a placebo once daily for 13 weeks, from 1 week before surgery to 12 weeks after surgery. Researchers will compare the two groups to assess postoperative infectious complications, other clinical outcomes, and changes in the gut microbiome.
- Conditions
- Colon Neoplasms
- Being tested
- Placebo, MPRO3
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Participants will receive one placebo capsule orally once daily after breakfast for 13 weeks.
MPRO3Dietary supplement
Participants will receive one MPRO3 capsule orally once daily after breakfast for 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is a matching formulation that does not contain the three probiotic strains included in MPR03. Receives: Dietary Supplement: Placebo |
| MPRO3 | Experimental | MPR03 is a probiotic formulation containing a mixture of three probiotic strains: Bifidobacterium animalis subsp. lactis HY8002, Lacticaseibacillus paracasei HY2782, and Lactiplantibacillus plantarum HY7712. Receives: Dietary Supplement: MPRO3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infectious Complications (Infectious complications)
The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria.
Measured: 4 weeks after surgery, 12 weeks after surgery
Secondary outcomes (11)
Comprehensive Complication Index
Postoperative complications are graded according to the Clavien-Dindo classification and summarized as a Comprehensive Complication Index score ranging from 0 to 100.
Measured: 4 weeks after surgery, 12 weeks after surgery
Postoperative Length of Hospital Stay (LOS)
Postoperative length of hospital stay is calculated from the date of surgery to hospital discharge based on medical records.
Measured: 4 weeks after surgery
Inflammation-related Marker 1: Glasgow prognostic score (GPS)
The Glasgow Prognostic Score (GPS) is assessed using inflammatory markers measured in venous blood and is calculated based on serum albumin and high-sensitivity C-reactive protein (HS-CRP) levels. The total score ranges from 0 to 2. A score of 0 is assigned when HS-CRP is ≤10 mg/L and albumin is ≥35 g/L. A score of 1 is assigned when either HS-CRP is >10 mg/L or albumin is <35 g/L. A score of 2 is assigned when HS-CRP is >10 mg/L and albumin is <35 g/L. Higher scores indicate a worse prognostic status.
Measured: Baseline, 4 weeks after surgery, 12 weeks after surgery
Inflammation-related Markers 2: White Blood Cell (WBC), C-reactive protein (CRP), Neutrophils, lymphocytes, Monocytes, Platelets (PLT), neutrophil-to-lymphocyte ratio (NLR)
Inflammation-related markers are assessed using venous blood samples. WBC and Platelets (PLT) are measured in 10^9/L. Neutrophils, lymphocytes, and Monocytes are reported as percentages (%). CRP is measured in mg/dL. The neutrophil-to-lymphocyte ratio (NLR) is reported as a unitless ratio.
Measured: Baseline, 4 weeks after surgery, 12 weeks after surgery
Inflammation Markers 3: Procalcitonin, Blood Culture (BC), Serum Amyloid A (SAA), Zonulin, Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, IL-17)
Procalcitonin, BC, SAA, Zonulin, Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, IL-17) are assessed using venous blood samples. Procalcitonin is measured in ng/mL, SAA in mg/L, and Zonulin in ng/mL. BC is recorded as a qualitative result (Positive/Negative). Cytokines assessed include TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, and IL-17, measured in pg/mL.
Measured: Baseline, 4 weeks after surgery, 12 weeks after surgery
Immune-related Markers 1: Natural Killer cell cytotoxicity (NK cytotoxicity), Natural Killer cell subset (NK subset)
Immune-related markers are assessed using venous blood samples. NK cytotoxicity and NK subset are reported as percentages (%).
Measured: Baseline, 4 weeks after surgery, 12 weeks after surgery
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is used to assess quality of life in patients with cancer. It consists of three domains: global health status/quality of life, functional, and symptom domains, with a total of 30 items. Scores are transformed to a scale ranging from 0 to 100 according to the EORTC QLQ-C30 scoring manual. Higher scores for global health status/quality of life and the functional domain indicate better quality of life, whereas higher scores for the symptom domain indicate worse quality of life.
Measured: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Bowel Function Assessment 1: Bowel Diary
As part of the bowel function assessment, a bowel diary is used to record the frequency and form of bowel movements.
Measured: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Bowel Function Assessment 2: Postoperative Bowel Function Questionnaire
As part of the bowel function assessment, the Postoperative Bowel Function Questionnaire is used to assess postoperative bowel function and recovery, including time to first passage of flatus, time to first bowel movement, and other related measures.
Measured: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Nutritional Status Assessment 1: Patient-Generated Subjective Global Assessment (PG-SGA)
As part of the nutritional status assessment, the Patient-Generated Subjective Global Assessment (PG-SGA) is used to evaluate nutritional status based on factors including changes in body weight and dietary intake, gastrointestinal symptoms affecting food intake, physical examination findings, and comorbidities.
Measured: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Nutritional Status Assessment 2: Prognostic Nutritional Index (PNI)
As part of the nutritional status assessment, the Prognostic Nutritional Index (PNI) is calculated based on Serum Albumin and Total Lymphocyte Count. PNI is calculated as 10 × Serum Albumin (g/dL) + 0.005 × Total Lymphocyte Count (/mm³).
Measured: 1 week before surgery, 4 weeks after surgery, 12 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 posted28 Aug 2026
- Study start4 Aug 2026
- Primary completion12 Apr 2028 (estimated)
- Study completion12 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hy Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutriworks, ImmunoBiome
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792980
- Sponsor's protocol ID
- 2026-1019
- Acronym
- AI-MPRO3
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients: A 13-Week, Randomized, Double-Blind, Placebo-Controlled Trial (AI-MPRO3 Study)
- ClinicalTrials.gov ID
- NCT07792980
- Acronym / sponsor ID
- AI-MPRO3 / 2026-1019
- Conditions
- Colon Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- hy Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Nutriworks, ImmunoBiome
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 12 Apr 2028 (estimated)
- Study completion
- 12 Apr 2028 (estimated)
- First posted
- 28 Aug 2026 (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 goal of this clinical trial is to evaluate the effects of MPRO3(probiotics mixture) supplementation on surgical outcomes and gut health in patients undergoing surgery for colon cancer.The main question is whether MPRO3 supplementation before and after surgery can reduce postoperative infectious complications compared with placebo.Participants will take either MPRO3 or a placebo once daily for 13 weeks, from 1 week before surgery to 12 weeks after surgery. Researchers will compare the two groups to assess postoperative infectious complications, other clinical outcomes, and changes in the gut microbiome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo is a matching formulation that does not contain the three probiotic strains included in MPR03. |
| MPRO3 | Experimental | Dietary Supplement: MPRO3MPR03 is a probiotic formulation containing a mixture of three probiotic strains: Bifidobacterium animalis subsp. lactis HY8002, Lacticaseibacillus paracasei HY2782, and Lactiplantibacillus plantarum HY7712. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A person who is diagnosed histologically or radiologically with adenocarcinoma of the colon and is scheduled to undergo surgery
Key exclusion criteria (13 listed)
- A person who has received chemotherapy or radiotherapy for colon cancer before surgery
- A person with fecal incontinence
- A person who has been diagnosed with an acute or serious disease, such as liver, kidney, heart, or thyroid disease, or is taking related medication
- A person with alcohol dependence or a history of drug abuse
- A person with immune system disorders, infectious diseases, or gastrointestinal diseases, including inflammatory bowel 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 |
|---|---|---|
| PlaceboParticipants will receive one placebo capsule orally once daily after breakfast for 13 weeks. | Dietary supplement | Placebo |
| MPRO3Participants will receive one MPRO3 capsule orally once daily after breakfast for 13 weeks. | Dietary supplement | MPRO3 |
Primary outcome
Postoperative Infectious Complications (Infectious complications)
Time frame: 4 weeks after surgery, 12 weeks after surgery
The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria.
11 secondary outcomes
Comprehensive Complication Index
Time frame: 4 weeks after surgery, 12 weeks after surgery
Postoperative Length of Hospital Stay (LOS)
Time frame: 4 weeks after surgery
Inflammation-related Marker 1: Glasgow prognostic score (GPS)
Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery
Inflammation-related Markers 2: White Blood Cell (WBC), C-reactive protein (CRP), Neutrophils, lymphocytes, Monocytes, Platelets (PLT), neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery
Inflammation Markers 3: Procalcitonin, Blood Culture (BC), Serum Amyloid A (SAA), Zonulin, Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-10, IL-12, IL-17)
Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery
Immune-related Markers 1: Natural Killer cell cytotoxicity (NK cytotoxicity), Natural Killer cell subset (NK subset)
Time frame: Baseline, 4 weeks after surgery, 12 weeks after surgery
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Bowel Function Assessment 1: Bowel Diary
Time frame: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Bowel Function Assessment 2: Postoperative Bowel Function Questionnaire
Time frame: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Nutritional Status Assessment 1: Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Nutritional Status Assessment 2: Prognostic Nutritional Index (PNI)
Time frame: 1 week before surgery, 4 weeks after surgery, 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Related trials for Colon Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPRO3 in people with Colon Neoplasms, run by hy Co., LTD. 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 1 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nayeon Song (+82-10-4365-1088, mind1088@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Infectious Complications (Infectious complications) (time frame: 4 weeks after surgery, 12 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 28 Aug 2026.