Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial
- Conditions
- Acute Pancreatitis
- Registration Number
- NCT06639516
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The number of days without SIRS within 14 days From randomization to 14 days after treatment 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
- Secondary Outcome Measures
Name Time Method Infectious complications During the whole study period including follow-up of 90 days The occurence of infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, and/or infected ascites，including fungal infections
Intestinal barrier function Through study completion, an average of 1 year Plasma endotoxin levels
Gut microbiota composition Baseline , 3 days，7 days and 14 days of treatment Fecal samples were collected from patients prior to the start of treatment, as well as on days 3, 7, and 14 after treatment. Subsequently, DNA was extracted from the feces, and the DNA was fragmented by Covaris M220 to screen for fragments of approximately 350 bp to be constructed into paired-end (Paired-End) DNA libraries. Next, libraries were constructed using NEXTFLEX Rapid DNA-Seq. Finally, these libraries were subjected to macro-genomic sequencing for in-depth analysis of microbial community structure and function in the samples.
Systemic inflammatory response parameters (SIRS) Through study completion, an average of 1 year Trends in CRP level changes
Gut function recovery-related indicators Through study completion, an average of 1 year Improvement in abdominal signs
Antibiotic usage Through study completion, an average of 1 year The number of days of antibiotic use
Mortality During the whole study period including follow-up of 90 days Occurence of death
(New onset) transient/persistant (multiple) organ failure During the whole study period including follow-up of 90 days The occurence of (new onset) transient/persistant (multiple) organ failure
Disease severity according to the revised Atlanta Classification During the whole study period including follow-up of 90 days Disease severity according to the revised Atlanta Classification
Length of hospital and/or ICU stay Through study completion, an average of 1 year Measured in days
The need (and number of) for surgical, endoscopic or radiologic interventions During the whole study period including follow-up of 90 days The need (and number of) for surgical, endoscopic or radiologic interventions
Readmissions During the whole study period including follow-up of 90 days The occurrence and number of readmissions
Trial Locations
- Locations (1)
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China