Age 18 to 80 YearsNCT07850089
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
A study testing High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G in people with Age 18 to 80 Years and Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, run by First Affiliated Hospital of Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, Hemodynamically Stable Within 24h Post-op, Per Investigator
- What is being tested?
- High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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/severe 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.
Trial 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
- Conditions
- Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, Hemodynamically Stable Within 24h Post-op, Per Investigator, Informed Consent Obtained Before Surgery or Randomization
- Being tested
- High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5GDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G |
| control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of surgery until GI-2 recovery, assessed up to 30 days after surgery
Secondary outcomes (4)
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.
Measured: Postoperative day 1 to 10
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.
Measured: On or after postoperative day 4
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.
Measured: Postoperative day 5, up to 30 days
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.
Measured: From baseline through 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age 18 to 80 YearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850089
- Sponsor's protocol ID
- KY2026-435
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07850089
- Acronym / sponsor ID
- KY2026-435
- Conditions
- Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, Hemodynamically Stable Within 24h Post-op, Per Investigator, Informed Consent Obtained Before Surgery or Randomization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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/severe 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.
Trial 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G |
| control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5GHighly 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. | Drug | Experimental group |
| PlaceboThe 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. | Drug | control group |
Primary outcome
Time from surgery end to GI-2 recovery.
Time frame: From the end of surgery until GI-2 recovery, assessed up to 30 days after surgery
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.
4 secondary outcomes
Daily I-FEED
Time frame: Postoperative day 1 to 10
Prolonged Postoperative Ileus
Time frame: On or after postoperative day 4
Nutritional Goal Attainment
Time frame: Postoperative day 5, up to 30 days
Safety Events
Time frame: From baseline through 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G in people with Age 18 to 80 Years and Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, run by First Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from surgery end to GI-2 recovery. (time frame: From the end of surgery until GI-2 recovery, assessed up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.