Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial

NCT ID: NCT06639516

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-12-01

Brief Summary

The purpose of this clinical trial is to investigate the impact of Bifidobacterium longum(BL) on the clinical prognosis of patients with acute pancreatitis(AP), to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.

Participants will be randomly assigned to two groups: the intervention group and the control group. They will receive:

• Intervention group: Standard clinical treatment + BL capsules (10^10 CFU), twice a day, for a total of 14 days;
• Control group: Standard clinical treatment + placebo capsules, for a total of 14 days.

A total of 60 patients will be included in this study.

Detailed Description

Rationale:The impairment of the intestinal mucosal barrier in patients with acute pancreatitis (AP) plays a crucial role in the progression to severe AP(SAP). Our previous research found that the early gut microbiota structure of AP patients is significantly different from that of healthy individuals, characterized by a marked increase in the relative abundance of conditional pathogens such as Escherichia coli and Shigella, while beneficial bacteria that produce short-chain fatty acids, such as Bifidobacterium, are significantly reduced, especially in patients with SAP. Bifidobacterium longum (BL), a well-known probiotic, has been used to treat a variety of diseases. In our previous animal experiments, we found that BL could alleviate pancreatic damage and inflammatory responses in AP mice and regulate the balance of the gut microbiota. Based on these findings, this study aims to assess the impact of BL on the clinical prognosis of AP patients through a randomized controlled trial, in order to provide a scientific basis for the application of BL in the treatment of AP and to further explore its potential clinical value.

Objective: The purpose of this clinical trial is to investigate the impact of BL on the clinical prognosis of patients with AP, to analyze the correlation between BL and intestinal barrier function, as well as the gut microbiota, and to observe adverse reactions and risks in patients with AP after the use of BL.

Study design: Single-center, randomized, double-blind, placebo-controlled study.

Study population:60 adult patients with acute pancreatitis. Intervention: The intervention group receives standard clinical treatment plus BL capsules (10^10 CFU), twice a day, for a total of 14 days; the control group receives standard clinical treatment plus placebo capsules, for a total of 14 days.

Main study parameters/endpoints: The primary endpoint is the number of days without SIRS within 14 days; the secondary endpoints include infectious complications (including fungal infections), parameters related to systemic inflammatory response, intestinal barrier function and gut microbiota composition, indicators related to recovery of intestinal function, antibiotic use, laboratory-related indicators, and clinical outcomes.

Safety: Throughout the study (or afterwards), treatment-emergent adverse events (TEAEs) were recorded, including gastrointestinal adverse reactions (abdominal pain, nausea, vomiting, bloating, or diarrhea) and allergic reactions, and adverse events that led to discontinuation of the study drug were documented.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Bifidobacterium longum capsules (10\^10 CFU) twice daily for 14 days

Group Type: EXPERIMENTAL

Bifidobacterium longum

Intervention Type: DIETARY_SUPPLEMENT

Bifidobacterium longum

Standard clinical treatment

Intervention Type: COMBINATION_PRODUCT

Fasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs).

Placebo group

Placebo capsules twice daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Standard clinical treatment

Intervention Type: COMBINATION_PRODUCT

Fasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs).

Interventions

Bifidobacterium longum

Bifidobacterium longum

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Standard clinical treatment

Fasting, gastrointestinal decompression, rehydration, inhibition of pancreatic fluid and pancreatic enzyme secretion, improvement of microcirculation, and support of organ function if organ dysfunction occurs at a later stage (mechanical ventilation, continuous renal replacement therapy, and the use of vasoactive drugs).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 year;

2. The diagnosis of acute pancreatitis according to the revised Atlanta classification;

3. The onset time of acute pancreatitis is within 48 hours;

4. APACHE II score of ≥8, or C-reactive protein > 150 mg/L, or SIRS score of ≥3;

5. Signed the informed consent.

Exclusion Criteria

1. Within 48 hours of onset, there is multi-organ failure;

2. Use of probiotics within the last month;

3. Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP);

4. Intra-operative diagnosis;

5. Infection/sepsis caused by a second disease;

6. Malignancy;

7. Immunocompromised patients;

8. Pregnancy and/or lactation;

9. Allergy to Bifidobacterium longum.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Lingyu Luo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cong He, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Central Contacts

yin zhu, PhD

Role: CONTACT

ndyfy01977@ncu.edu.cn

+8613970847464

Facility Contacts

Cong He, PhD

Role: primary

hecong.1987@163.com

+8613807032823

Other Identifiers

Bifidobacterium Longum

Identifier Type: -

Identifier Source: org_study_id