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Clostridium butyricum improves perioperative intestinal function and immune status in patients with colorectal cancer: a randomized controlled trial

Clostridium butyricum improves perioperative intestinal function and immune status in patients with colorectal cancer: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033883
Enrollment
Unknown
Registered
2020-06-15
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Experimental group:Clostridium butyricum

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed as colorectal adenocarcinoma by preoperative fiberoptic colonoscopy and pathological examination; 2. Radical surgery for laparoscopic/open colon cancer/rectal cancer; 3. Aged 18 to 80 years old; 4. The laboratory test results before entering the group meet the following surgical conditions: neutrophil (ANC) >= 1.5x10^9/L, platelet (PLT) >=100x10^9/L, total bilirubin (TBI) <=1.5 ULN (2mg/dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) <=2 ULN; coagulation parameters are in the normal range; 5. The patient has no psychological, family, social, or geographic restrictive factors that affect protocol compliance and follow-up time; 6. Patient signs informed consent.

Exclusion criteria

Exclusion criteria: 1. Other types of colorectal cancer (adenosquamous carcinoma, squamous cell carcinoma, neuroendocrine tumors, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma) 2. Those who have recently taken similar micro-ecological preparations; 3. Those with acute or chronic infections or infections before surgery; 4. Those who cannot take probiotics on time according to the research plan; 5. Radical surgery was not performed for various reasons during the operation; 6. Acute abdomen: intestinal obstruction, intestinal crush, peritonitis, etc.; 7. Merging other parts to transfer; 8. There are serious heart, lung, liver, and kidney diseases, and the operation cannot be tolerated; 9. Liver disease active period or abnormal liver function, ALT, AST, TBIL are more than 2 ULN; 10. Renal impairment, Cr >=2 ULN or BUN >=2 ULN; 11. Subjects whose blood leukocytes are below the lower limit of normal, or platelets are below the lower limit of normal, or have other blood system diseases; 12. Those with mental illness or intellectual disability who cannot describe their feelings correctly; 13. Severe coagulation mechanism disorder, bleeding tendency; 14. There are serious uncontrolled medical diseases, recent history of myocardial infarction (within 3 months); acute infection; 15. After intervention treatment, uncontrolled severe hypertension and severe diabetes patients; 16. Those who are allergic to test drugs; 17. Have a history of alcohol, drug or drug abuse; 18. Those who have participated in any drug trial within 3 months before being selected; 19. The investigator believes that other candidates are not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
First flatus time;Intestinal flora diversity;

Secondary

MeasureTime frame
T lymphocyte subsets;Serum inflammatory factor;

Countries

China

Contacts

Public ContactYanlei Ma

Department of Colorectal Surgery, Fudan University Shanghai Cancer Center

yanleima@fudan.edu.cn+86 13122680635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026