Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD

NCT ID: NCT06719596

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2025-06-28

Brief Summary

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Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

Detailed Description

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Conditions

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Infectious Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD

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

Group Type EXPERIMENTAL

Bifidobacterium Bifidum Oral Capsule

Intervention Type DRUG

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

Control group

Conventional postoperative treatment of the pancreas combined with enteral nutrition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bifidobacterium Bifidum Oral Capsule

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu XU FUXU

Role: CONTACT

Phone: +86 182 0518 8516

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2024-225-01

Identifier Type: -

Identifier Source: org_study_id