Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the 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: Outp...
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| Format: | Article |
| Language: | Russian |
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Gastro LLC
2022-09-01
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| Series: | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
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| Online Access: | https://www.gastro-j.ru/jour/article/view/743 |
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| author | Yu. O. Shulpekova I. V. Maev V. B. Grinevich I. B. Khlynov Yu. G. Shvarts V. T. Ivashkin |
| author_facet | Yu. O. Shulpekova I. V. Maev V. B. Grinevich I. B. Khlynov Yu. G. Shvarts V. T. Ivashkin |
| author_sort | Yu. O. Shulpekova |
| collection | DOAJ |
| description | 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: Outpatients (N = 309) at the age of 18–45 in whom FD 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. ITT and [PP] analysis were performed.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 = 0.046 [p = 0.051]). None of the patients in Kolofort® group had progression of FD symptoms or required additional therapy. There were 29 adverse events (AEs) recorded in 25 patients 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. |
| format | Article |
| id | doaj-art-a00c484531884361a8f62cfae43def23 |
| institution | Kabale University |
| issn | 1382-4376 2658-6673 |
| language | Russian |
| publishDate | 2022-09-01 |
| publisher | Gastro LLC |
| record_format | Article |
| series | Российский журнал гастроэнтерологии, гепатологии, колопроктологии |
| spelling | doaj-art-a00c484531884361a8f62cfae43def232025-02-10T16:14:37ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732022-09-01323405110.22416/1382-4376-2022-32-3-40-51488Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled TrialYu. O. Shulpekova0I. V. Maev1V. B. Grinevich2I. B. Khlynov3Yu. G. Shvarts4V. T. Ivashkin5I.M. Sechenov First Moscow State Medical University (Sechenov University)Moscow State University of Medicine and Dentistry named after A.I. YevdokimovS. M. Kirov Military Medical AcademyUral State Medical UniversitySaratov State Medical University named after V. I. RazumovskyI.M. Sechenov First Moscow State Medical University (Sechenov University)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: Outpatients (N = 309) at the age of 18–45 in whom FD 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. ITT and [PP] analysis were performed.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 = 0.046 [p = 0.051]). None of the patients in Kolofort® group had progression of FD symptoms or required additional therapy. There were 29 adverse events (AEs) recorded in 25 patients 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.https://www.gastro-j.ru/jour/article/view/743functional dyspepsiaplacebo-controlled trialtechnologically-treated polyclonal affinity-purified antibodies to the tumor necrosis factor-αbrain specific s-100 protein and histamineefficacy assessmentsafety profile |
| spellingShingle | Yu. O. Shulpekova I. V. Maev V. B. Grinevich I. B. Khlynov Yu. G. Shvarts V. T. Ivashkin Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Российский журнал гастроэнтерологии, гепатологии, колопроктологии functional dyspepsia placebo-controlled trial technologically-treated polyclonal affinity-purified antibodies to the tumor necrosis factor-α brain specific s-100 protein and histamine efficacy assessment safety profile |
| title | Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full | Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| title_fullStr | Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| title_full_unstemmed | Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| title_short | Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| title_sort | technologically treated polyclonal affinity purified antibodies to the tumor necrosis factor α brain specific s 100 protein and histamine in treatment of functional dyspepsia results of the multicenter randomized double blind placebo controlled trial |
| topic | functional dyspepsia placebo-controlled trial technologically-treated polyclonal affinity-purified antibodies to the tumor necrosis factor-α brain specific s-100 protein and histamine efficacy assessment safety profile |
| url | https://www.gastro-j.ru/jour/article/view/743 |
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