Clinical trial NCT06639516: Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial
Official title: Therapeutic Effect of Bifidobacterium Longum in Patients with Acute Pancreatitis: a Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
Probiotics
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \&amp;amp;gt; 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.

Primary outcomes:
measure: The number of days without SIRS within 14 days
timeFrame: From randomization to 14 days after treatment
Secondary outcomes:
measure: Infectious complications
timeFrame: During the whole study period including follow-up of 90 days
measure: Intestinal barrier function
timeFrame: Through study completion, an average of 1 year
measure: Intestinal barrier function
timeFrame: Through study completion, an average of 1 year
measure: Intestinal barrier function
timeFrame: Through study completion, an average of 1 year
measure: Gut microbiota composition
timeFrame: Baseline , 3 days，7 days and 14 days of treatment
measure: Systemic inflammatory response parameters (SIRS)
timeFrame: Through study completion, an average of 1 year
measure: Systemic inflammatory response parameters (SIRS)
timeFrame: Through study completion, an average of 1 year
measure: Systemic inflammatory response parameters (SIRS)
timeFrame: Through study completion, an average of 1 year
measure: Gut function recovery-related indicators
timeFrame: Through study completion, an average of 1 year
measure: Antibiotic usage
timeFrame: Through study completion, an average of 1 year
measure: Mortality
timeFrame: During the whole study period including follow-up of 90 days
measure: (New onset) transient/persistant (multiple) organ failure
timeFrame: During the whole study period including follow-up of 90 days
measure: Disease severity according to the revised Atlanta Classification
timeFrame: During the whole study period including follow-up of 90 days
measure: Length of hospital and/or ICU stay
timeFrame: Through study completion, an average of 1 year
measure: The need (and number of) for surgical, endoscopic or radiologic interventions
timeFrame: During the whole study period including follow-up of 90 days
measure: Readmissions
timeFrame: During the whole study period including follow-up of 90 days
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Cong He, PhD
role: PRINCIPAL_INVESTIGATOR
References: