Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery

NCT07850089 | Not Yet Recruiting

• 1 other identifier: KY2026-435
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To evaluate the effects of the postbiotic preparation JK-5G on gastrointestinal function recovery (GI-2 time), gastrointestinal dysfunction, nutritional status, and safety in patients after surgery for malignant bowel obstruction. Design: A randomized, double-blind, placebo-controlled, exploratory clinical trial. Patients are randomized 1:1 within 24 hours after surgery. After meeting criteria for initiating enteral intake, they receive either JK-5G or placebo (one sachet three times daily) for 10 consecutive days, and are followed up to postoperative day 30. Study Population: Adult patients (18-80 years old) who undergo surgery for malignant mechanical bowel obstruction and are hemodynamically stable within 24 hours after surgery. Sample Size: A total of 80 patients (40 in the postbiotic group and 40 in the placebo group). A blinded review of variability will be conducted after 40 patients have completed the study. Primary Endpoint: Time from the end of surgery to GI-2 recovery, where GI-2 recovery is defined as the later of the following two events: first passage of stool/effective stoma output, and first tolerance of the target diet. Key secondary endpoints include daily I-FEED scores, incidence of prolonged postoperative ileus, achievement of nutritional targets, and safety events. Statistics and Timeline: The primary analysis will use a stratified Cox model (intention-to-treat principle). The study is planned to be conducted from September 2026 to February 2028.

Conditions

Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief; Age 18 to 80 Years; Hemodynamically Stable Within 24h Post-op, Per Investigator; Informed Consent Obtained Before Surgery or Randomization

Outcome Measures

Primary Outcomes (1)

• Time from surgery end to GI-2 recovery.

  GI-2 is defined as the later of the following two events: (1) first passage of stool; in patients with a stoma, the first clinically meaningful spontaneous stoma output, excluding mere bloody fluid, irrigant, or mucus; and (2) first tolerance of the protocol-specified target diet, with no return to fasting/clear fluids only due to nausea, vomiting, or abdominal distension within the subsequent 24 hours, and no need for reinsertion of nasogastric decompression. The primary endpoint will be adjudicated by an outcome assessor who is independent of the clinical treatment decisions.

  From the end of surgery until GI-2 recovery, assessed up to 30 days after surgery

Secondary Outcomes (4)

• Daily I-FEED

  Postoperative day 1 to 10

• Prolonged Postoperative Ileus

  On or after postoperative day 4

• Nutritional Goal Attainment

  Postoperative day 5, up to 30 days

• Safety Events

  From baseline through 30 days after surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G

control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G DRUG

Highly concentrated compound lactic acid bacteria metabolites JK-5G is mainly composed of inactivated lactic acid bacterial strains (such as Lactococcus lactis, approximately 21 species of Lactobacillus, etc.) and their bioactive metabolites. Its important components include short-chain fatty acids (SCFAs) and inactivated lactic acid bacteria.

Experimental group

Placebo DRUG

The placebo is completely identical to JK-5G in appearance, color, particle size, taste, odor, packaging, labeling, and reconstitution characteristics. It does not contain lactic acid bacteria metabolites, live bacteria, inactivated bacterial cells, or any other ingredients with known microecological activity.

control group

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria to be enrolled:
• Age 18-80 years.
• Diagnosed with malignant mechanical bowel obstruction based on clinical and imaging findings, and have undergone abdominal surgery for the purpose of relieving the obstruction.
• Vital signs are stable within 24 hours after surgery, and the investigator judges that the subject can continue to participate in the trial.
• Written informed consent has been signed by the subject or their legally authorized representative before surgery or before randomization.

You may not qualify if:

• Subjects meeting any of the following criteria will not be enrolled:
• Presence of unresolved mechanical obstruction after surgery, or planned re-laparotomy in the short term.
• Short bowel syndrome or severe intestinal fistula.
• Persistent hemodynamic instability requiring continuous vasopressors or mechanical ventilation after surgery, or severe hepatic/renal failure that, in the investigator's opinion, makes enteral intervention inappropriate.
• Allergy to any component of the postbiotic preparation.
• Pregnancy or lactation.
• Concurrent participation in another interventional clinical trial.
• Any other condition that, in the investigator's judgment, makes the subject unsuitable for enrollment.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09