Randomized Controlled Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 14, 2021; 27(2): 224-232
Published online Jan 14, 2021. doi: 10.3748/wjg.v27.i2.224
Effect of probiotics on length of hospitalization in mild acute pancreatitis: A randomized, double-blind, placebo-controlled trial
You-Dong Wan, Rui-Xue Zhu, Zhong-Zheng Bian, Tong-Wen Sun
You-Dong Wan, Tong-Wen Sun, Integrated Intensive Care Unit, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan Province, China
Rui-Xue Zhu, Health Management Centre, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
Zhong-Zheng Bian, Department of Emergency Medicine, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
Author contributions: Wan YD wrote the paper; Wan YD and Zhu RX collected and analyzed the data; Wan YD, Zhu RX, Bian ZZ, and Sun TW designed the study, critically reviewed the manuscript, and approved the final version.
Supported by National Natural Science Foundation of China, No. 81370364.
Institutional review board statement: The study was ethically approved by the Ethics Committee of The Affiliated Hospital of Qingdao University.
Clinical trial registration statement: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000030425).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare no conflict of interests for this article.
CONSORT 2010 statement: The authors have read the CONSORT Statement—checklist of items, and the manuscript was prepared and revised according to the CONSORT Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Tong-Wen Sun, MD, Chief Doctor, Professor, Integrated Intensive Care Unit, The First Affiliated Hospital of Zhengzhou University, No. 1 Jianshe East Road, Zhengzhou 450052, Henan Province, China. wanyoudong123@163.com
Received: November 5, 2020
Peer-review started: November 5, 2020
First decision: November 25, 2020
Revised: November 29, 2020
Accepted: December 16, 2020
Article in press: December 16, 2020
Published online: January 14, 2021
Research background

Acute pancreatitis is one of the most common causes of acute abdominal pain, resulting in a huge clinical and financial burden worldwide. Most patients (80%) with acute pancreatitis present with mild disease, which is characterized by a short hospital stay, no or few complications, and rapid resumption of oral feeding. Allowing for the very low mortality rate (about 0.79%) of mild acute pancreatitis, shortening the length of hospital stay (LOS), and reducing medical financial expenditure have become the research priority.

Research motivation

Probiotics play an important role in a variety of microecologic interventions. The effects of probiotics in mild acute pancreatitis have not been studied. Considering the potential benefits of probiotics in the treatment of gastrointestinal disease, we hypothesized that probiotics may accelerate the recovery of intestinal function and shorten the LOS in patients with mild pancreatitis. Thus, we conducted a randomized, double-blind, placebo-controlled trial to evaluate the effect of the administration of probiotics in patients with mild pancreatitis.

Research objectives

This study was designed to investigate the value of probiotics in reducing the LOS in patients with mild acute pancreatitis.

Research methods

We conducted a double-blind randomized clinical trial to evaluate the effects of probiotics administered to patients with mild acute pancreatitis at a tertiary medical center. The patients were given probiotics capsules (a mixed preparation of Bacillus subtilis and Enterococcus faecium) or placebo. The primary study endpoint was the LOS. The secondary endpoints included time to abdominal pain relief, recurrent abdominal pain, and time to successful oral feeding.

Research results

A total of 128 patients were included, with 64 patients in each arm. The severity of illness and the etiological distribution of disease were similar in the two groups. There was a significant reduction in the LOS in the probiotics treatment group vs the placebo group (5.36 ± 0.15 vs 6.02 ± 0.17 d, P < 0.05). The probiotics group was associated with a shorter time to abdominal pain relief and time to successful oral feeding (P < 0.01 for both) than the placebo group. No statistical difference was found in recurrent abdominal pain between the two groups.

Research conclusions

The study results showed that the administration of probiotics capsule is associated with a shorter duration of hospitalization in patients with mild acute pancreatitis.

Research perspectives

Probiotics supplementation appears to be safe and effective in reducing the length of hospitalization for patients with mild acute pancreatitis in this double-blinded randomized clinical trial. However, the sample size is small and the follow-up time is short in this study. In future studies, a randomized study with a larger sample using different types and doses of probiotics can be conducted to further clarify the role of probiotics in acute pancreatitis and other uninvestigated gastrointestinal diseases.