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

NCT06639516 | Not Yet Recruiting

• 1 other identifier: Bifidobacterium Longum
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis; Probiotics

Outcome Measures

Primary Outcomes (1)

• The number of days without SIRS within 14 days

  Patients were randomized into the study group and remained free of SIRS up to 14 days after enrollment, with the total number of SIRS-free days counted

  From randomization to 14 days after treatment

Secondary Outcomes (16)

• Infectious complications

  During the whole study period including follow-up of 90 days

• Intestinal barrier function

  Through study completion, an average of 1 year

• Intestinal barrier function

  Through study completion, an average of 1 year

• Intestinal barrier function

  Through study completion, an average of 1 year

• Gut microbiota composition

  Baseline , 3 days，7 days and 14 days of treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Dietary Supplement: Bifidobacterium longum; Combination Product: Standard clinical treatment

Placebo group

PLACEBO COMPARATOR

Placebo capsules twice daily for 14 days

Dietary Supplement: Placebo; Combination Product: Standard clinical treatment

Interventions

Bifidobacterium longum DIETARY_SUPPLEMENT

Bifidobacterium longum

Intervention group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Standard clinical treatment 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).

Intervention group; Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 year;
• The diagnosis of acute pancreatitis according to the revised Atlanta classification;
• The onset time of acute pancreatitis is within 48 hours;
• APACHE II score of ≥8, or C-reactive protein \> 150 mg/L, or SIRS score of ≥3;
• Signed the informed consent.

You may not qualify if:

• Within 48 hours of onset, there is multi-organ failure;
• Use of probiotics within the last month;
• Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP);
• Intra-operative diagnosis;
• Infection/sepsis caused by a second disease;
• Malignancy;
• Immunocompromised patients;
• Pregnancy and/or lactation;
• Allergy to Bifidobacterium longum.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Cong He, PhD

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yin zhu, PhD

CONTACT

+8613970847464; ndyfy01977@ncu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 15, 2024
• Study Start: February 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)