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Clinical Observation Study on the Efficacy and Safety of Prophylactic Use of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules in Promoting Intestinal Function Recovery After Laparoscopic Radical Resection of Colorectal Cancer

Clinical Observation Study on the Efficacy and Safety of Prophylactic Use of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules in Promoting Intestinal Function Recovery After Laparoscopic Radical Resection of Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096039
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

colorectal cancer

Interventions

Placebo control group:In the placebo-controlled group, a single dose of 2 placebo capsules is administered. The placebo, provided by Beijing Hanmi Pharmaceutical Co., Ltd., is in the form of a capsule
Treatment group:In the treatment group, a single dose of 2 capsules of Bacillus subtilis and Enterococcus faecalis Enteric-Coated Capsules is administered. All patients receive a single dose (Bacillus

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 35-65 years old; 2) Patients undergoing laparoscopic radical resection of colorectal cancer; 3) Patients voluntarily accept microecological therapy; 4) Operation duration is 2 to 6 hours; 5) The patient signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) suffering from cognitive impairment (such as Alzheimer's disease, depression, bipolar disorder, etc.); 2) Have a history of abdominal surgery or allergic reaction to subtilis enteric-coated capsules; 3) The amount of blood lost during surgery exceeds 500mL; 4) Less than 3 months after participating in or completing other clinical trials; 5) Received broad-spectrum antibiotics within 3 months before surgery; 6) dysfunction of heart, liver and other vital organs; 7) Used probiotics within 3 months before surgery; 8) There are known causes of gastrointestinal dysfunction before surgery; 9) History of preoperative radiotherapy or chemotherapy; 10) History of preoperative use of anticoagulants and (or) antiplatelet drugs.

Design outcomes

Primary

MeasureTime frame
postoperative time to first flatus;Time of first feeding after surgery;the time of first formed stool after surgery;

Secondary

MeasureTime frame
hospitalization duration;postoperative anastomotic leak incidence;incidence of intestinal obstruction;

Countries

China

Contacts

Public ContactPengyuanWang

Peking University First Hospital

pengyuan_wang@bjmu.edu.cn+86 139 1115 8750

Outcome results

None listed

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