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A New Approach to the Management of Functional Dyspepsia: Results of a Multicenter, Randomized, Double-blind, Placebo-controlled Trial


 The aim of the study was to evaluate the efficacy and safety of Kolofort (a complex medicine containing technologically processed forms of antibodies to S-100 protein, tumor necrosis factor-α and histamine) in the management of functional dyspepsia (FD) in outpatient clinical practice.Methods: 309 outpatients at the age of 18-45 in whom functional dyspepsia was diagnosed according to the Rome IV criteria were enrolled in a multicenter, double-blind, placebo-controlled, randomized clinical trial. Patients were randomized in two groups receiving Kolofort or Placebo 2 tablets tid for 8 weeks. The primary endpoint of the study was a change in the FD symptoms severity score according to the Gastrointestinal symptom score (GIS) at week 8. The demand in accessory medications was also assessed.Results: at week 8 the reduction in GIS sum score was observed in Kolofort group and Placebo group (by 7.2±3.3 [7.2±3.4] and 6.3±4.6 [6.2±4.5], respectively, p=0.041 [0.039]). The proportion of cases with GIS score reduction by ≥4 was 88.1% [88.6%] and 79.1% [79.6%] in Kolofort group and Placebo group, respectively (p=0.051 [p=0.046]). None of the patients in Kolofort group had experienced progression of FD symptoms or required additional therapy. 29 AEs were recorded including 16 cases in 13 (8.6%) patients in Kolofort group and 13 AEs in 12 (7.6%) patients in Placebo group.Conclusion: the clinical trial demonstrates the positive effect of Kolofort in FD with a favorable safety profile.