[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658193":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":51,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":61,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":30,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":30},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fclear 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",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"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.","Postoperative day 1 to 10",{"measure":19,"description":20,"timeFrame":21},"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\u002Fvomiting within the past 24 hours; ② inability to tolerate oral\u002Fenteral feeding; ③ no passage of flatus or stool within the past 24 hours; ④ abdominal distension; ⑤ radiological findings supportive of ileus.","On or after postoperative day 4",{"measure":23,"description":24,"timeFrame":25},"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\u002Fprotein intake, and number of days on parenteral nutrition will be recorded.","Postoperative day 5, up to 30 days",{"measure":27,"description":28,"timeFrame":29},"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\u002Fvomiting, and 30-day mortality.","From baseline through 30 days after surgery",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"SINGLE",[38],"PARTICIPANT","Project Title: A Randomized, Double-Blind, Placebo-Controlled Exploratory Clinical Trial of Highly Concentrated Compound Lactic Acid Bacteria Metabolites JK-5G for Promoting Gastrointestinal Function Recovery After Surgery for Malignant Bowel Obstruction Study Objective: To evaluate the effects of JK-5G on GI-2 recovery time, gastrointestinal dysfunction, nutritional recovery, and safety after surgery for malignant bowel obstruction Study Population: Adult patients who undergo surgery for malignant mechanical bowel obstruction and are haemodynamically stable within 24 hours after surgery Sample Size: Exploratory sample size of 80 cases (40 in the postbiotic group and 40 in the placebo group); a blinded variability review will be conducted after 40 patients have completed the study Inclusion Criteria: Aged 18-80 years; diagnosed with malignant-related mechanical bowel obstruction and have undergone surgery to relieve the obstruction; stable within 24 hours after surgery; informed consent signed Exclusion Criteria Residual mechanical obstruction or planned re-operation; short bowel syndrome\u002Fsevere intestinal fistula; haemodynamic instability requiring continuous circulatory or respiratory support; allergy to the product; inability to discontinue other microecological preparations; pregnancy or lactation; concurrent participation in another interventional clinical trial; etc.\n\nTrial Design: 1:1 randomised, double-blind, placebo-controlled within 24 hours after surgery; after reaching the criteria for initiating enteral intake, patients receive either JK-5G or placebo (one sachet three times daily) for 10 consecutive days; those who do not start the intervention continue to be followed up and are included in the ITT analysis Endpoint Measures: Primary endpoint: time from end of surgery to GI-2 recovery. Key secondary endpoints: daily I-FEED score, prolonged postoperative ileus, achievement of nutritional targets, and safety events. Other secondary endpoints include gastrointestinal recovery, hospitalisation, and 30-day outcomes Statistical Analysis: Primary analysis uses a stratified Cox model, reporting hazard ratios and 95% confidence intervals; ITT is the primary analysis, supported by per-protocol and safety sets; pre-specified sensitivity analyses for death, re-operation, and missing data Study Duration: Each patient is followed up to postoperative day 30; the overall study is planned from September 2026 to February 2028",[41,46],{"label":42,"type":43,"description":30,"interventionNames":44},"Experimental group","EXPERIMENTAL",[45],"Drug: High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G",{"label":47,"type":48,"description":30,"interventionNames":49},"control group","PLACEBO_COMPARATOR",[50],"Drug: Placebo",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":30},"DRUG","High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G","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.",[42],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":30},"Placebo","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.",[47],{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100658193","postbiotics-for-gi-recovery-after-malignant-bowel-obstruction-surgery-100658193",false,"NCT07850089","Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery","Effects of Preparations of Fermented Metabolites Derived From Lactic Acid Bacteria on Postoperative Gastrointestinal Function Recovery After Resolution of Malignant Bowel Obstruction: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Clinical Study","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Age 18-80 years.\n2. Diagnosed with malignant mechanical bowel obstruction based on clinical and imaging findings, and have undergone abdominal surgery for the purpose of relieving the obstruction.\n3. Vital signs are stable within 24 hours after surgery, and the investigator judges that the subject can continue to participate in the trial.\n4. Written informed consent has been signed by the subject or their legally authorized representative before surgery or before randomization.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be enrolled:\n\n1. Presence of unresolved mechanical obstruction after surgery, or planned re-laparotomy in the short term.\n2. Short bowel syndrome or severe intestinal fistula.\n3. Persistent hemodynamic instability requiring continuous vasopressors or mechanical ventilation after surgery, or severe hepatic\u002Frenal failure that, in the investigator's opinion, makes enteral intervention inappropriate.\n4. Allergy to any component of the postbiotic preparation.\n5. Continuous use of other probiotics, prebiotics, synbiotics, or postbiotics within 2 weeks prior to randomization and inability to discontinue them; perioperative prophylactic or therapeutic antibiotics are not exclusion criteria but must be fully documented.\n6. Pregnancy or lactation.\n7. Concurrent participation in another interventional clinical trial.\n8. Any other condition that, in the investigator's judgment, makes the subject unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.\n\nDesign: 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.\n\nStudy Population: Adult patients (18-80 years old) who undergo surgery for malignant mechanical bowel obstruction and are hemodynamically stable within 24 hours after surgery.\n\nSample 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.\n\nPrimary 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\u002Feffective 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.\n\nStatistics 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.",[81,82,83,84],"Age 18 to 80 Years","Malignant Mechanical Bowel Obstruction Diagnosed Clinically\u002FRadiologically, With Prior Abdominal Surgery for Relief","Hemodynamically Stable Within 24h Post-op, Per Investigator","Informed Consent Obtained Before Surgery or Randomization","NOT_YET_RECRUITING","2026-09-29",{"date":88,"type":89},"2026-09-30","ACTUAL",{"date":91,"type":75},"2026-09",{"date":93,"type":75},"2028-09",{"name":5,"class":6}]