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

Condition(s) studied

Investigational drug(s) / intervention(s)

Bifidobacterium longum: Bifidobacterium longum

Placebo: Placebo

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).

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More The First Affiliated Hospital of Nanchang University trials in China

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