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

ConditionAcute Pancreatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bifidobacterium longum

    Dietary supplement

    Bifidobacterium longum

  • Placebo

    Dietary supplement

    Placebo

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Placebo groupPlacebo comparator 2 interventions

Trial outcomes

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

Time frame
From randomization to 14 days after treatment

Secondary outcomes

1

Infectious complications

The occurence of infected pancreatic necrosis, bacteremia, pneumonia, urosepsis, and/or infected ascites，including fungal infections

Time frame
During the whole study period including follow-up of 90 days
2

Intestinal barrier function

Plasma D-lactate(D-lac）

Time frame
Through study completion, an average of 1 year
3

Intestinal barrier function

Diamine oxidase activity(DAO)

Time frame
Through study completion, an average of 1 year
4

Intestinal barrier function

Plasma endotoxin levels

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Nanchang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: