Health TrialsbyHealthPanel

Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery

ConditionsAge 18 to 80 YearsMalignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for ReliefHemodynamically Stable Within 24h Post-op, Per InvestigatorInformed Consent Obtained Before Surgery or Randomization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Daily I-FEED

Daily assessment from day 1 to 10 after surgery. An I-FEED score of 0-2 means normal recovery, 3-5 means gastrointestinal intolerance, and ≥6 means gastrointestinal dysfunction.

Time frame
Postoperative day 1 to 10
2

Prolonged Postoperative Ileus

Presence of at least 2 of the following 5 criteria on or after postoperative day 4, after excluding mechanical obstruction or other identifiable causes: ① nausea/vomiting within the past 24 hours; ② inability to tolerate oral/enteral feeding; ③ no passage of flatus or stool within the past 24 hours; ④ abdominal distension; ⑤ radiological findings supportive of ileus.

Time frame
On or after postoperative day 4
3

Nutritional Goal Attainment

Achievement of ≥60% of target energy intake on postoperative day 5. Additionally, the time to reaching ≥80% of target energy intake, daily energy/protein intake, and number of days on parenteral nutrition will be recorded.

Time frame
Postoperative day 5, up to 30 days
4

Safety Events

Adverse events (AEs) and serious adverse events (SAEs) during the treatment period, CTCAE grading, discontinuation of study product, as well as anastomotic leakage, intra-abdominal infection, surgical site infection, diarrhoea, abdominal pain, nausea/vomiting, and 30-day mortality.

Time frame
From baseline through 30 days after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: