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

hy Co., LTD.

Status: Enrolling

Conditions: Colon Neoplasms

Treatments: Dietary Supplement: MPRO3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07792980

2026-1019

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

MPRO3

Experimental group

Description:

MPR03 is a probiotic formulation containing a mixture of three probiotic strains: Bifidobacterium animalis subsp. lactis HY8002, Lacticaseibacillus paracasei HY2782, and Lactiplantibacillus plantarum HY7712.

Treatment:

Dietary Supplement: MPRO3