Lumbar Degenerative DiseaseNCT07893938
Perioperative Nutrition Management in Patients Undergoing Open Posterior Lumbar Surgery
A study testing Oral nutritional supplements (ONS), Carbohydrate loading (OCL) and 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)' in people with Lumbar Degenerative Disease and Lumbar Spondylolisthesis, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
Patients undergoing open posterior lumbar fusion surgery often experience postoperative gastrointestinal problems, such as bloating, constipation, and delayed passage of gas and stool, and may be at nutritional risk. These problems may hinder recovery and prolong hospital stay. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Degenerative Disease, Lumbar Spondylolisthesis, Lumbar Disc Herniation
- What is being tested?
- Oral nutritional supplements (ONS), Carbohydrate loading (OCL) and 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with a non-infectious spinal condition for which open posterior lumbar fusion surgery is planned in the Department of Orthopedics
- No recent abnormal dietary status and no recent use of probiotic preparations
- Scheduled to undergo posterior lumbar fusion under general anesthesia (mainly short-segment)
- Able to understand the study and willing to provide signed informed consent
Who cannot join
- Presence of chronic or infectious diseases (e.g., chronic kidney disease, history of malignancy, pulmonary infection, primary spinal infection)
- Immunocompromised or immunodeficient, or taking immunosuppressive medication due to disease
- Preoperative malnutrition or hypoalbuminemia (albumin < 35 g/L)
- High bleeding risk (e.g., coagulation dysfunction, preoperative anemia, severe cardiac, hepatic, or renal dysfunction, recent use of antiplatelet or anticoagulant drugs)
- Pre-existing lower-extremity deep vein thrombosis at admission
- Intolerance or allergy to the study drugs or nutritional supplements
Show all 10Show fewer
- Severe digestive or absorptive dysfunction
- Poorly controlled diabetes or hypertension
- Emergency surgery
- Any condition that, in the investigator's judgment, would prevent the patient from meeting the study requirements
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
About this study
Official title: Perioperative Nutrition Management in Patients Undergoing Open Posterior Lumbar Surgery: A Comparative Study of No Intervention, Nutrition Support, and Combined Probiotic Therapy
Patients undergoing open posterior lumbar fusion surgery often experience postoperative gastrointestinal problems, such as bloating, constipation, and delayed passage of gas and stool, and may be at nutritional risk. These problems may hinder recovery and prolong hospital stay.
This study enrolled 90 patients undergoing open posterior lumbar fusion surgery at the Department of Orthopedics, First Affiliated Hospital of Kunming Medical University. Participants were randomly assigned in a 1:1:1 ratio to three groups: a control group receiving routine perioperative care with standard dietary guidance; experimental group A receiving perioperative oral nutritional supplements (ONS) together with preoperative and postoperative carbohydrate loading; and experimental group B receiving the same ONS and carbohydrate loading plus a probiotic preparation.
Read more
The primary outcome was the length of postoperative hospital stay. Other assessments included time to first postoperative flatus, time to first postoperative bowel movement, cumulative postoperative drainage volume, drainage duration, and time to first postoperative mobilization out of bed. Surgical wound healing, postoperative infections, and overall postoperative complications were assessed during hospitalization and at the outpatient follow-up visit 1 month after surgery. Additional assessments included anthropometric measurements, laboratory tests, and scores evaluating pain, function, nutritional risk, nutritional status, dietary intake, and gastrointestinal function.
Anthropometric measurements were obtained at hospital admission and at the pre-discharge assessment. The Visual Analog Scale (VAS) for overall pain, Japanese Orthopaedic Association (JOA) low back pain score, Nutritional Risk Screening 2002 (NRS-2002), full Mini Nutritional Assessment (MNA), Simple Diet Self-Assessment Tool (SDSAT), and simplified gastrointestinal function score were assessed at hospital admission, on postoperative day 3, at the pre-discharge assessment, and at 1 month after surgery. Laboratory tests were performed before surgery and on postoperative days 1, 3, and 6.
The aim was to evaluate the clinical value of perioperative nutrition management in spinal surgery and explore whether adding probiotics provided further benefit. The study was intended to inform the development of a practical perioperative nutrition management plan to support recovery, shorten hospital stay, and reduce postoperative complications.
- Being tested
- Oral nutritional supplements (ONS), Carbohydrate loading (OCL), 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'
- Keywords
- Perioperative nutrition, Oral nutritional supplements, Probiotics, Enhanced recovery after surgery, Posterior lumbar fusion
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplements (ONS)Dietary supplement
Perioperative optimized oral nutritional supplements (whole-nutrient formula plus whey protein; diabetes-specific formula for patients with diabetes), taken as between-meal snacks from 2 days before surgery to 5 days after surgery, to reach an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day.
Carbohydrate loading (OCL)Dietary supplement
Preoperative and postoperative oral carbohydrate loading. A 12.5% carbohydrate drink is given as 400 ml at 10 hours and 200 ml at 2 hours before surgery, and 200 ml after waking from anesthesia, followed by a liquid and semi-liquid diet as tolerated.
'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'Biological
Bifidobacterium and Lactobacillus triple live capsules (a live microbial preparation), 2 g orally three times daily, from 2 days before surgery to 5 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine perioperative care with standard dietary guidance. Patients receive routine dietary counseling after a nutrition consultation, conventional preoperative fasting (no food or drink for more than 8 hours), and a gradual diet transition from liquids to regular food after passage of gas. No oral nutritional supplements or probiotics are provided. |
| Experimental group A | Experimental | Optimized perioperative oral nutritional supplements (ONS) plus preoperative and postoperative carbohydrate loading. ONS is given from 2 days before surgery to 5 days after surgery, with an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day. Receives: Dietary Supplement: Oral nutritional supplements (ONS); Dietary Supplement: Carbohydrate loading (OCL) |
| Experimental group B | Experimental | ONS plus carbohydrate loading (identical to group A) plus a probiotic preparation. Bifidobacterium and Lactobacillus triple live capsules (2 g orally three times daily) are added from 2 days before surgery to 5 days after surgery. Receives: Dietary Supplement: Oral nutritional supplements (ONS); Dietary Supplement: Carbohydrate loading (OCL); Biological: 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Number of days from surgery to hospital discharge during the index hospitalization.
Measured: From surgery to hospital discharge during the index hospitalization, up to 17 days after surgery.
Secondary outcomes (36)
Time to first postoperative flatus
Time from the end of surgery to the first passage of flatus, measured in hours.
Measured: From returning to the ward after surgery until the first passage of flatus, up to 29 hours after surgery.
Time to first postoperative bowel movement
Time from the end of surgery to the first bowel movement, measured in hours.
Measured: From returning to the ward after surgery until the first bowel movement, up to 126 hours after surgery.
Total postoperative drainage volume
Cumulative postoperative drainage volume collected until drain removal, measured in milliliters.
Measured: After surgery until drain removal, up to postoperative day 7.
Postoperative drainage duration
Duration from postoperative day 1 to drain removal, measured in days.
Measured: From postoperative day 1 until drain removal, up to postoperative day 7.
Time to first postoperative out-of-bed mobilization
Timing of the first postoperative mobilization out of bed after the end of surgery, recorded as the postoperative day number. Postoperative day 1 is the calendar day after surgery.
Measured: From the end of surgery until the first mobilization out of bed, up to postoperative day 8.
Percentage of participants with impaired surgical wound healing
Percentage of participants with impaired healing of the surgical incision, based on clinical observation during the index hospitalization and reassessment at the outpatient follow-up visit 1 month after surgery. Each participant with impaired wound healing is counted once.
Measured: During the index postoperative hospitalization (up to 17 days after surgery) and at 1 month after surgery.
Percentage of participants with postoperative infections
Percentage of participants who experienced at least one postoperative infection by 1 month after surgery. Infections include surgical incision infections, pulmonary infections (including pneumonia), urinary tract infections, and deep tissue infections. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or sites of infection.
Measured: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Percentage of participants with postoperative complications
Percentage of participants who experienced at least one postoperative complication by 1 month after surgery. Complications include postoperative infections, gastrointestinal reactions (abdominal distension, constipation, or diarrhea), impaired surgical wound healing, lower-limb deep vein thrombosis, renal insufficiency, and pressure ulcers. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or types of complication.
Measured: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Body mass index
Body mass index calculated as body weight in kilograms divided by height in meters squared, reported in kg/m^2.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Triceps skinfold thickness
Triceps skinfold thickness, measured in millimeters.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm circumference
Mid-upper arm circumference, measured in centimeters.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm muscle circumference
Mid-upper arm muscle circumference, reported in centimeters.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mean bilateral handgrip strength
Arithmetic mean of the left- and right-hand grip strength measurements, reported in kilograms.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist circumference
Waist circumference, measured in centimeters.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Hip circumference
Hip circumference, measured in centimeters.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist-to-hip ratio
Waist circumference divided by hip circumference, with both measurements expressed in centimeters. The ratio is dimensionless.
Measured: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Visual Analog Scale score for overall pain
Overall pain intensity assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Japanese Orthopaedic Association low back pain score
Low back symptoms and function assessed using the Japanese Orthopaedic Association (JOA) low back pain score. The score includes subjective symptoms (0 to 9 points), clinical signs (0 to 6 points), activities of daily living (0 to 14 points), and urinary bladder function (-6 to 0 points). The total score ranges from -6 to 29 points, with higher scores indicating better clinical status and function.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Nutritional Risk Screening 2002 score
Nutritional risk assessed using Nutritional Risk Screening 2002 (NRS-2002). The total score is the sum of the impaired nutritional status score (0 to 3) and the disease severity score (0 to 3), with 1 additional point for participants aged 70 years or older. The total score ranges from 0 to 7, with higher scores indicating greater nutritional risk.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Mini Nutritional Assessment total score
Nutritional status assessed using the full 18-item Mini Nutritional Assessment (MNA). The screening section (0 to 14 points) and assessment section (0 to 16 points) are summed to obtain a total score ranging from 0 to 30. Higher scores indicate better nutritional status.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simple Diet Self-Assessment Tool score
Dietary intake assessed using the five-level Simple Diet Self-Assessment Tool (SDSAT) shown in the study assessment form. Scores range from 1 to 5. Higher scores indicate greater estimated dietary energy and protein intake.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simplified gastrointestinal function score
Gastrointestinal dysfunction assessed in three domains: abdominal distension or pain, nausea or vomiting, and diarrhea. Each domain is scored from 0 to 5. The overall score is the highest of the three domain scores and ranges from 0 (normal gastrointestinal function) to 5 (severe impairment). Higher scores indicate worse gastrointestinal dysfunction.
Measured: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
White blood cell count
White blood cell count, reported in 10^9/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
C-reactive protein
C-reactive protein concentration, reported in mg/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Erythrocyte sedimentation rate
Erythrocyte sedimentation rate, reported in mm/h.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Serum albumin
Serum albumin concentration, reported in g/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Total lymphocyte count
Total lymphocyte count, reported in 10^9/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Hemoglobin
Hemoglobin concentration, reported in g/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Total cholesterol
Total cholesterol concentration, reported in mmol/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (LDL-C) concentration, reported in mmol/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol (HDL-C) concentration, reported in mmol/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Triglycerides
Triglyceride concentration, reported in mmol/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Prealbumin
Prealbumin concentration, reported in mg/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Transferrin
Transferrin concentration, reported in g/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Retinol-binding protein
Retinol-binding protein concentration, reported in mg/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Creatinine
Creatinine concentration, reported in micromol/L.
Measured: Before surgery and on postoperative days 1, 3, and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start22 May 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1:1 ratio to three parallel groups: a control group, an experimental group A (oral nutritional supplements plus carbohydrate loading), and an experimental group B (oral nutritional supplements plus carbohydrate loading plus probiotics).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Wang, First Affiliated Hospital of Kunming Medical University
- Investigators
- Bing Wang, MD, Study director, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893938
- Sponsor's protocol ID
- 2025-L-134
- Other IDs
- No.82260449, No.82460441
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutrition Management in Patients Undergoing Open Posterior Lumbar Surgery: A Comparative Study of No Intervention, Nutrition Support, and Combined Probiotic Therapy
- ClinicalTrials.gov ID
- NCT07893938
- Acronym / sponsor ID
- 2025-L-134
- Keywords
- Perioperative nutrition, Oral nutritional supplements, Probiotics, Enhanced recovery after surgery, Posterior lumbar fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 26 Oct 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.
Patients undergoing open posterior lumbar fusion surgery often experience postoperative gastrointestinal problems, such as bloating, constipation, and delayed passage of gas and stool, and may be at nutritional risk. These problems may hinder recovery and prolong hospital stay.
This study enrolled 90 patients undergoing open posterior lumbar fusion surgery at the Department of Orthopedics, First Affiliated Hospital of Kunming Medical University. Participants were randomly assigned in a 1:1:1 ratio to three groups: a control group receiving routine perioperative care with standard dietary guidance; experimental group A receiving perioperative oral nutritional supplements (ONS) together with preoperative and postoperative carbohydrate loading; and experimental group B receiving the same ONS and carbohydrate loading plus a probiotic preparation.
The primary outcome was the length of postoperative hospital stay. Other assessments included time to first postoperative flatus, time to first postoperative bowel movement, cumulative postoperative drainage volume, drainage duration, and time to first postoperative mobilization out of bed. Surgical wound healing, postoperative infections, and overall postoperative complications were assessed during hospitalization and at the outpatient follow-up visit 1 month after surgery. Additional assessments included anthropometric measurements, laboratory tests, and scores evaluating pain, function, nutritional risk, nutritional status, dietary intake, and gastrointestinal function.
Anthropometric measurements were obtained at hospital admission and at the pre-discharge assessment. The Visual Analog Scale (VAS) for overall pain, Japanese Orthopaedic Association (JOA) low back pain score, Nutritional Risk Screening 2002 (NRS-2002), full Mini Nutritional Assessment (MNA), Simple Diet Self-Assessment Tool (SDSAT), and simplified gastrointestinal function score were assessed at hospital admission, on postoperative day 3, at the pre-discharge assessment, and at 1 month after surgery. Laboratory tests were performed before surgery and on postoperative days 1, 3, and 6.
The aim was to evaluate the clinical value of perioperative nutrition management in spinal surgery and explore whether adding probiotics provided further benefit. The study was intended to inform the development of a practical perioperative nutrition management plan to support recovery, shorten hospital stay, and reduce postoperative complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned in a 1:1:1 ratio to three parallel groups: a control group, an experimental group A (oral nutritional supplements plus carbohydrate loading), and an experimental group B (oral nutritional supplements plus carbohydrate loading plus probiotics).
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine perioperative care with standard dietary guidance. Patients receive routine dietary counseling after a nutrition consultation, conventional preoperative fasting (no food or drink for more than 8 hours), and a gradual diet transition from liquids to regular food after passage of gas. No oral nutritional supplements or probiotics are provided. |
| Experimental group A | Experimental | Dietary Supplement: Oral nutritional supplements (ONS), Dietary Supplement: Carbohydrate loading (OCL)Optimized perioperative oral nutritional supplements (ONS) plus preoperative and postoperative carbohydrate loading. ONS is given from 2 days before surgery to 5 days after surgery, with an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day. |
| Experimental group B | Experimental | Dietary Supplement: Oral nutritional supplements (ONS), Dietary Supplement: Carbohydrate loading (OCL), Biological: 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'ONS plus carbohydrate loading (identical to group A) plus a probiotic preparation. Bifidobacterium and Lactobacillus triple live capsules (2 g orally three times daily) are added from 2 days before surgery to 5 days after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with a non-infectious spinal condition for which open posterior lumbar fusion surgery is planned in the Department of Orthopedics
- No recent abnormal dietary status and no recent use of probiotic preparations
- Scheduled to undergo posterior lumbar fusion under general anesthesia (mainly short-segment)
- Able to understand the study and willing to provide signed informed consent
Key exclusion criteria (10 listed)
- Presence of chronic or infectious diseases (e.g., chronic kidney disease, history of malignancy, pulmonary infection, primary spinal infection)
- Immunocompromised or immunodeficient, or taking immunosuppressive medication due to disease
- Preoperative malnutrition or hypoalbuminemia (albumin < 35 g/L)
- High bleeding risk (e.g., coagulation dysfunction, preoperative anemia, severe cardiac, hepatic, or renal dysfunction, recent use of antiplatelet or anticoagulant drugs)
- Pre-existing lower-extremity deep vein thrombosis at admission
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 |
|---|---|---|
| Oral nutritional supplements (ONS)Perioperative optimized oral nutritional supplements (whole-nutrient formula plus whey protein; diabetes-specific formula for patients with diabetes), taken as between-meal snacks from 2 days before surgery to 5 days after surgery, to reach an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day. | Dietary supplement | Experimental group A, Experimental group B |
| Carbohydrate loading (OCL)Preoperative and postoperative oral carbohydrate loading. A 12.5% carbohydrate drink is given as 400 ml at 10 hours and 200 ml at 2 hours before surgery, and 200 ml after waking from anesthesia, followed by a liquid and semi-liquid diet as tolerated. | Dietary supplement | Experimental group A, Experimental group B |
| 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'Bifidobacterium and Lactobacillus triple live capsules (a live microbial preparation), 2 g orally three times daily, from 2 days before surgery to 5 days after surgery. | Biological | Experimental group B |
Primary outcome
Length of postoperative hospital stay
Time frame: From surgery to hospital discharge during the index hospitalization, up to 17 days after surgery.
Number of days from surgery to hospital discharge during the index hospitalization.
36 secondary outcomes
Time to first postoperative flatus
Time frame: From returning to the ward after surgery until the first passage of flatus, up to 29 hours after surgery.
Time to first postoperative bowel movement
Time frame: From returning to the ward after surgery until the first bowel movement, up to 126 hours after surgery.
Total postoperative drainage volume
Time frame: After surgery until drain removal, up to postoperative day 7.
Postoperative drainage duration
Time frame: From postoperative day 1 until drain removal, up to postoperative day 7.
Time to first postoperative out-of-bed mobilization
Time frame: From the end of surgery until the first mobilization out of bed, up to postoperative day 8.
Percentage of participants with impaired surgical wound healing
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at 1 month after surgery.
Percentage of participants with postoperative infections
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Percentage of participants with postoperative complications
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Body mass index
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Triceps skinfold thickness
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm circumference
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm muscle circumference
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mean bilateral handgrip strength
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist circumference
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Hip circumference
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist-to-hip ratio
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Visual Analog Scale score for overall pain
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Japanese Orthopaedic Association low back pain score
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Nutritional Risk Screening 2002 score
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Mini Nutritional Assessment total score
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simple Diet Self-Assessment Tool score
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simplified gastrointestinal function score
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
White blood cell count
Time frame: Before surgery and on postoperative days 1, 3, and 6.
C-reactive protein
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Erythrocyte sedimentation rate
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Serum albumin
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Total lymphocyte count
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Hemoglobin
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Total cholesterol
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Low-density lipoprotein cholesterol
Time frame: Before surgery and on postoperative days 1, 3, and 6.
High-density lipoprotein cholesterol
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Triglycerides
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Prealbumin
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Transferrin
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Retinol-binding protein
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Creatinine
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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. This study is not recruiting at the moment.
Bing Wang, MD study director
First Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplements (ONS), Carbohydrate loading (OCL) and 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)' in people with Lumbar Degenerative Disease and Lumbar Spondylolisthesis, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of postoperative hospital stay (time frame: From surgery to hospital discharge during the index hospitalization, up to 17 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 3 Nov 2026.