Probiotic supplementation induces remission and changes in the immunoglobulins and inflammatory response in active ulcerative colitis patients: A pilot, randomized, double-blind, placebo-controlled study

Abstract

Background & aims: Clinical studies of using probiotics for managing ulcerative colitis (UC) in Jordan are rare. Therefore, we aimed to evaluate the effect of probiotic supplementation on the clinical disease activity and biochemical parameters in patients with mild-to-moderately active UC.

Methods: thirty mild-to-moderate ulcerative colitis patients were included and randomly assigned to participate in a double-blinded randomized study to receive the treatment (3 × 10¹⁰ of probiotic capsules [containing nine Lactobacillus and five Bifidobacterium species], or a placebo), and included in the intention-to-treat analysis. Only 24 completed the study and were included in the per-protocol analysis. Both groups were compared in terms of clinical disease activity and biochemical parameters at the beginning and the end of the study. Registered under ClinicalTrials.gov Identifier no. NCT04223479.

Results: There was a significant induction of remission in the probiotic group presented by improvement in the partial mayo score (PMS). Probiotic group had significantly lower stool frequency (0.00 ± 0.00 vs. 1.17 ± 1.19), global assessment (0.42 ± 0.51 vs. 1.00 ± 0.74, p = 0.035), and total PMS score (1.33 ± 0.49 vs. 3.42 ± 1.78). In terms of mean and percent of change in post-to pre-treatment values, there was a significant reduction in C-reactive protein, and an increase in hemoglobin, hematocrit, and RBC levels in the probiotic group (p < 0.05). Additionally, there was a significant reduction in the IgA level and an increase in IL-10 levels among the probiotic group compared to the placebo group (p = 0.039).

Conclusions: The use of probiotic therapy had significantly induced remission in UC patients, this was evidenced by the improvement in the Partial Mayo score. Furthermore, probiotic therapy had an appropriate effect on changes in hemoglobin, hematocrit, C-reactive protein, IgA, and IL-10 levels. This study was registered at ClinicalTrials.gov with the number NCT04223479.

Keywords: A randomized trial; C-reactive protein; Clinical disease activity; Immunoglobulins; Inflammatory markers; Probiotics; Ulcerative colitis.