Abstract
Objective — to evaluate the clinical efficacy and safety of Inulin‑Neo 5 in patients with irritable bowel syndrome with constipation and to analyze the effects of treatment on the patients’ gut microbiome.
 Materials and methods. Observations involved 75 patients with irritable bowel syndrome and constipation (IBS‑C) aged 23 to 54 years. There were 32 men and 46 women. For the period of the study, all patients kept a diary where they recorded the stool frequency, abdominal pain severity (AP), the degree of flatulence and general well‑being. Patients evaluated AB on a visual analog scale before treatment, on the 14th day of therapy and after the end of the course of drugs administration. To diagnose the state of the gut microbiota, the presence of bacterial overgrowth syndrome (SIBO) was determined using a hydrogen breath test with lactulose load. Changes in the main bacterial enterotypes were analyzed in 60 patients by qRT‑PCR using primers targeted at 16S rRNA. Bacteroidetes, Firmicutes, Actinobacteria, butyrate‑producing bacteria Faecalibacterium prausnitzii, Akkermansia muciniphila and methanogenic archaea Methanobrevibacter smithii were studied. After randomization, 30 IBS‑C patients received monotherapy with Inulin‑Neo 5 in a dose of 12.0 g/day for 4 weeks, and 45 patients took laxatives. Patients in both groups could take antispasmodics as needed.
 Results. In case of Inulin‑Neo 5 administration by patients with IBS‑C, the abdominal pain decreased, stool frequency normalized, and the intensity of flatulence decreased. The clinical effects of Inulin‑Neo 5 were stipulated by its prebiotic properties and the positive impact of the gut microbiome. After the course of therapy with Inulin‑Neo 5, patients with IBS‑C demonstrated the reduction in the frequency of SIBO detection and intensity, the raise in levels of Bacteroidetes and regulatory butyrate‑producing bacteria Faecalibacterium prausnitzii and Akkermansia muciniphila with a decrease in the levels of Firmicutes and methanogenic flora Methanobrevibacter smithii.
 Conclusions. Inulin‑Neo 5 demonstrated efficacy and safety in the treatment of patients with IBS‑C. With its use, stools returned to normal in patients, promoting the decrease in abdominal pain and flatulence; clinical efficacy was combined with positive effects on the intestinal microflora.
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