Effect of Synbiotics in Reducing the Systemic Inflammatory Response and Septic Complications in Moderately Severe and Severe Acute Pancreatitis: A Prospective Parallel-Arm Double-Blind Randomized Trial

Abstract

Aim This study aimed at evaluating the efficacy of synbiotics in reducing septic complications in moderately severe and severe acute pancreatitis.Methods This was a prospective, parallel-arm, double-blinded superiority randomized control study. All patients with moderately severe and severe acute pancreatitis were included in the study. Acute on chronic pancreatitis, pancreatitis due to trauma, ERCP and malignancy were excluded. 1 g of synbiotic containing both pre- and probiotics was administered to the cases twice a day for 14 days and a similar-looking placebo to controls. Patients were followed for 90 days. Primary outcomes were reduction of septic complications and inflammatory marker levels. Secondary outcomes were mortality, non-septic morbidity, length of hospitalization (LOH) and need for intervention.Results A total of 86 patients were randomized to 43 in each arm. Demographic profile and severity of pancreatitis were comparable. There was no significant difference in septic complications between the groups (59% vs. 64%; p 0.59). Total leucocyte and neutrophil counts showed a significant reduction in the first 7 days (p = 0.01 and 0.05). No significant difference was seen in other inflammatory markers. There was a significant reduction in the LOH (10 vs. 7; p = 0.02). Non-septic morbidity (41% vs. 62.2%; p 0.06) and length of ICU stay (3 vs. 2; p 0.06) had a trend towards significance. The need for intervention and mortality was comparable.Conclusion Synbiotics did not significantly reduce the septic complications in patients with moderately severe and severe acute pancreatitis; however, they significantly reduced the LOH. There was no reduction in mortality and need for intervention. Clinical Trials Registry of India Number: CTRI/2018/03/012597.