Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD

NCT06719596 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-225-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Conditions

Infectious Complications

Outcome Measures

Primary Outcomes (1)

• infectious complication

  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

  30 days after surgery

Study Arms (2)

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

EXPERIMENTAL

enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID

Drug: Bifidobacterium Bifidum Oral Capsule

Control group

NO INTERVENTION

Conventional postoperative treatment of the pancreas combined with enteral nutrition

Interventions

Bifidobacterium Bifidum Oral Capsule DRUG

enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

321 Zhongshan Road, Nanjing Gulou Hospital, Gulou District, Nanjing, Jiangsu Province, China

Nanjing, Jiangsu, 222000, China

RECRUITING

Central Study Contacts

Fu XU FUXU

CONTACT

+86 182 0518 8516; fuxunju2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: May 10, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 28, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-11

Locations

CN (1)