Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD (2024-225-01)

Nanjing University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Infectious Complications

Treatments: Drug: Bifidobacterium Bifidum Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06719596

2024-225-01

Details and patient eligibility

About

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Experimental group

Description:

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

Treatment:

Drug: Bifidobacterium Bifidum Oral Capsule

Control group

No Intervention group

Description:

Conventional postoperative treatment of the pancreas combined with enteral nutrition