Supplementation with Lactobacillus reuteri ATCC PTA 4659 in patients affected by acute uncomplicated diverticulitis: a randomized double-blind placebo controlled trial

Abstract

Introduction: Acute uncomplicated diverticulitis (AUD) is an inflammation of the colon diverticulum. We tested the efficacy of Lactobacillus reuteri 4659 (L. reuteri) in treating AUD. Primary outcome was reduced abdominal pain and inflammatory markers (C-RP). Secondary outcome was reduced hours of hospitalization.

Patients and methods: A double-blind, placebo RCT was conducted with 88 (34M/54F mean age 61.9 ± 13.9) patients with a diagnosis of AUD. Group A (44 patients, 26F): ciprofloxacin 400 mg/bid and metronidazole 500 mg/tid for 1 week, plus L. reuteri/bid for 10 days. Group B (44 patients, 28F): same antibiotic therapy for 1 week, plus placebo/bid for 10 days. All patients completed a daily visual analog scale (VAS) for abdominal pain.

Results: Between days 1 and 3, the group A pain decreased by 4.5 points; group B decreased by 2.36 points (p < 0.0001). Between days 1 and 5, the group A decreased by 6.6 points; group B by 4.4 points (p < 0.0001). Between days 1 and 7, the group A decreased by 7.6 points; group B decreased by 5.6 points (p < 0.0001). Between days 1 and 10, the group A decreased by 8.1 points; group B decreased by 6.7 points (p < 0.0001). For C-RP value, the mean decrease between admission and after 72 h was 45.3 mg/L for group A and 27.49 mg/L for group B (p < 0.0001).

Conclusions: Our RCT showed that supplementation of the standard AUD therapy with L. reuteri strain 4659 significantly reduced abdominal pain and inflammatory markers compared with the placebo group. It also resulted in a shorter period of hospitalization, and thus has economic benefits.

Trial registration: TRIALGOV: NCT03656328.

Keywords: Acute uncomplicated diverticulitis; Inflammatory markers; Lactobacillus reuteri.