Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD

Phase 1

Recruiting

• Conditions: Infectious Complications
• Interventions: Drug: Bifidobacterium Bifidum Oral Capsule

• Registration Number: NCT06719596
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Status Verified: 2024-11
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Adult patients greater than 18 years of age;
• Indication for elective pancreaticoduodenal surgery;
• Patients who understand the nature of the trial and are willing and able to provide written consent

Exclusion Criteria

. Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications.

Inability to tolerate PD due to cardiopulmonary function and other parameters

• Received radiotherapy before surgery
• Emergency PD surgery
• Pregnant and breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD	Bifidobacterium Bifidum Oral Capsule	enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID

Primary Outcome Measures

Name	Time	Method
infectious complication	30 days after surgery	1. Post-operative infections: Surgical site infections (SSI): including surgical incision infections and abdominal cavity infections.; (1) incision infection: purulent secretions in the incision and culture of pathogenic bacteria (2) abdominal cavity infection: diagnosis can be made by meeting one of the following criteria: ① postoperative symptoms of systemic infection (fever \> 38 ° C, white blood cell count higher than the upper limit of normal values), accompanied by abdominal distension, abdominal pain, and signs of peritonitis; ② abdominal drainage or puncture drainage fluid is purulent fluid, positive bacteriological culture results; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess in the abdominal cavity; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess. (iii) ultrasound or CT imaging or re-surgical confirmation of the presence of intra-abdominal ex

Trial Locations

Locations (1)

321 Zhongshan Road, Nanjing Gulou Hospital, Gulou District, Nanjing, Jiangsu Province, China; 🇨🇳 Nanjing, Jiangsu, China