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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Seoul ST. Mary's Hospital

    Seoul, Seoul

    Nayeon Song, +82-10-4365-1088, mind1088@naver.com

    Ingyu Lee

    Recruiting

Other trials in South Korea

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 groups in NCT07792980
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo is a matching formulation that does not contain the three probiotic strains included in MPR03.
Receives: Dietary Supplement: Placebo
MPRO3ExperimentalMPR03 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted28 Aug 2026
  2. Study start4 Aug 2026
  3. Primary completion12 Apr 2028 (estimated)
  4. Study completion12 Apr 2028 (estimated)

Resources

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)
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

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.

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