Efficacy and Safety of Faecal Microbiota Transplantation for Acute Pancreatitis: A Randomised, Controlled Study

Ling Ding,Yan Cai,Huajing Ke,Yuanhang Liao,Yupeng Lei,Yin Zhu,Qinyu Yang,Wenhua He,Xueyang Li,Cong He,Hongyan Chen,Huifang Xiong,Liang Xia,Nonghua Lu,Xin Huang

doi:10.3389/fmed.2021.772454

Abstract

Aims: We investigated whether faecal microbiota transplantation (FMT) decreases intra-abdominal pressure (IAP) and improves gastrointestinal (GI) dysfunction and infectious complications in acute pancreatitis (AP).Methods: In this first randomised, single-blind, parallel-group, controlled study, we recruited and enrolled consecutive patients with AP complicated with GI dysfunction. Eligible participants were randomly assigned to receive faecal transplant (n = 30) or normal saline (n = 30) via a nasoduodenal tube once and then again 2 days later. The primary endpoint was the rate of IAP decline; secondary endpoints were GI function, infectious complications, organ failure, hospital stay and mortality. Analyses were based on intention to treat.Results: We enrolled 60 participants and randomly assigned them to the FMT (n = 30) or control (n = 30) group. Baseline characteristics and disease severity were similar for both groups. IAP decreased significantly 1 week after intervention in both groups, with no difference in the IAP decline rate between FMT and Control group [0.1 (−0.6, 0.5) vs. 0.2 (−0.2, 0.6); P = 0.27]. Normal gastrointestinal failure (GIF) scores were achieved in 12 (40%) patients in the FMT group and 14 (47%) in the control group, with no significant difference (P = 0.60). However, D-lactate was significantly elevated in the FMT group compared to the control group, as calculated by the rate of decline [−0.3 (−3.7, 0.8) vs. 0.4 (−1.1, 0.9); P = 0.01]. Infectious complications occurred in 15 (50%) and 16 (53.33%) patients in the FMT and control groups, respectively (P = 0.80). However, interleukin-6 (IL-6) was significantly elevated in the FMT group compared to the control group, as calculated by the rate of decline [0.4 (−3.6, 0.9) vs. 0.8 (−1.7, 1.0); P = 0.03]. One participant experienced transient nausea immediately after FMT, but no serious adverse events were attributed to FMT.Conclusion: FMT had no obvious effect on IAP and infectious complications in AP patients, though GI barrier indictors might be adversely affected. Further multi-centre studies are needed to confirm our findings. The study was registered at https://clinicaltrials.gov (NCT02318134).

Highlights

Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas
Between November 2017 and April 2019, 388 consecutive patients were assessed for eligibility; 328 were excluded for not having GI dysfunction (n = 147), age 70 years old (n = 37), time from AP onset to enrolment >2 weeks (n = 18), GI haemorrhage (n = 2), multiple organ failure (n = 46), diabetes (n = 26), pregnancy (n = 1), or declining to participate (n = 51)
All analyses were performed on the basis of the intention-to-treat principle (Figure 1)

Summary

Introduction

Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas. 80% of AP cases are mild and self-limited, and ∼20% of patients have a severe disease course with persistent organ failure (OF) and/or infected pancreatic necrosis (IPN), with a mortality risk as high as 20∼30% [3]. The gastrointestinal (GI) tract is considered a target organ during systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) and a “motor organ” of gut-derived infection [4, 5]. GI microbiota dysbiosis induces injury to the biological barrier, which plays a key role in the pathogenesis of gut-driven infection.

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Conclusion