Efficacy and safety of fecal microbiota transplantationin patients with mild-to-moderate non-specific ulcerative colitis

Abstract

Objective — to study the clinical and microbiological effectiveness, tolerability and safety of fecal microbiota transplantation (FMT) in patients with mild–to‑moderate nonspecific ulcerative colitis (NUC).Materials and methods. A single‑center, open, comparative, randomized clinical trial was conducted to study the effectiveness of FMT in patients with active mild‑to‑moderate NUC. Examinations involved 56 patients (36 men and 20 women) aged 22 to 48 years (mean age 32 ± 12 years) with verified mild‑to‑moderate NUC in the active phase. The severity of the NUC course and the degree of its activity was assessed based on the criteria of Truelove and Witt, as well as the endoscopic index of the NUC severity, the number of points on the Mayo scale and the level of fecal calprotectin. Depending on the treatment, all patients with NUC were randomized into 2 groups with the use of a computer random number method in a ratio of 1 : 1. Group I patients (10 women, 18 men) received basic mesalazine therapy in a daily dose of 3 g (2 g orally + 1 g rectally). In the second group, at baseline and against the background of mesalazine administration in the specified dose, each patient with NUC (19 men, 9 women) was undergone a single FMT procedure in which fecal material from a healthy superdonor was used. From them, fresh material was used in 14 cases and in 14 cases material was the frozen up to –80 ° С. Assessment of the clinical effectiveness of treatment in both groups was carried out after 4 and 8 weeks. An incomplete Mayo scale was used to assess the achievement of clinical remission, and fecal calprotectin levels were also studied. Besides, in all patients, before and 1 month after the treatment, the study of intestinal microbiome (IM) was performed at the level of the main microbial phylotypes by determining the DNA of Firmicutes, Bacteroidetes and Actinobacteria, as well as Faecalibacterium prausnitzii in fecal samples using quantitative polymerase chain reaction in real time.Results. The performance of a single FMT allowed to improve the results of the NUC basic treatment of with mesalazine, which manifested itself in the form of a significantly higher number of patients with clinical improvement after 4 weeks, a significantly lower number of patients requiring escalation of treatment, a significantly greater decrease in the Mayo index after 8 weeks, a significantly higher number of patients with clinical remission after 8 weeks. The fecal calprotectin level, despite a considerable decrease, in the specified time did not reach the norm, which indicates the need for prolongation of basic therapy. There were no serious adverse reactions to FMT, and mild adverse reactions were noted in 8 (28.6 %) patients. The clinical efficacy of treatment in both groups of patients was accompanied by an improvement in the state of IM (normalization of Bacteroidetes, an increase in the number of Firmicutes and Faecalibacterium prausnitzii, a decrease in the number of Actinobacteria) significantly more pronounced in the group of patients with NUC who were additionally treated with FMT.Conclusions. In a certain part of patients with mild‑to‑moderate NUC, even once performed FMT is a well‑tolerated and safe treatment method that promoted the increase of basic therapy effectiveness after 4 and 8 weeks, as well as significantly improved the condition of IM already 4 weeks after its implementation.