AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients

NCT07792980 | Recruiting DMC

• 1 other identifier: 2026-1019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Postoperative Infectious Complications (Infectious complications)

  The occurrence of postoperative infectious complications is assessed according to the CDC/NHSN criteria.

  4 weeks after surgery, 12 weeks after surgery

Secondary Outcomes (11)

• Comprehensive Complication Index

  4 weeks after surgery, 12 weeks after surgery

• Postoperative Length of Hospital Stay (LOS)

  4 weeks after surgery

• Inflammation-related Marker 1: Glasgow prognostic score (GPS)

  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)

  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)

  Baseline, 4 weeks after surgery, 12 weeks after surgery

Other Outcomes (3)

• Fecal Microbiome (16S/Shotgun, NGS, SCFA)

  1 week before surgery, 4 weeks, 12 weeks after surgery

• Tumor Transcriptome (RNA-seq)

  During surgery

• Adaptive immunity test (T cell exhaustion marker, CEA/NY-ESO-1/ST4-specific T cell)

  Baseline, 4 weeks, 12 weeks after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo is a matching formulation that does not contain the three probiotic strains included in MPR03.

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.

Dietary Supplement: MPRO3

Interventions

Placebo DIETARY_SUPPLEMENT

Participants will receive one placebo capsule orally once daily after breakfast for 13 weeks.

Placebo

MPRO3 DIETARY_SUPPLEMENT

Participants will receive one MPRO3 capsule orally once daily after breakfast for 13 weeks.

MPRO3

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person who is diagnosed histologically or radiologically with adenocarcinoma of the colon and is scheduled to undergo surgery

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• hy Co., LTD.: lead
• Nutriworks: collaborator
• ImmunoBiome: collaborator

Study Sites (1)

Seoul ST. Mary's Hospital

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Nayeon Song

CONTACT

+82-10-4365-1088; mind1088@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 12, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

KR (1)