Efficiency of using domestic enteral formula with metabolic action in children with cystic fibrosis
N.D. Odinaeva, E.I. Kondratieva, T.L. Pilat, I.R. Fatkhullina, E.K. Zhekaite, Yu.G. Kuznetsova
Background: A consistently high level of endogenous intoxication in children with cystic fibrosis (CF) is one of the links in the pathogenesis of CF progression, the severity of clinical manifestations and the development of complications.
Objective: Evaluation of the clinical efficacy of domestic specialized enteral formulas with a metabolic action «Protein Detoxification Cocktail NUTRIO» and «Protein Detoxification Cocktail» («LEOVIT nutrio» LLC, Russia) in diet therapy for children with CF.
Materials and methods: The study included 43 patients with CF aged 3 to 17 years 11 months who were undergoing treatment and rehabilitation at the Research Clinical Institute of Childhood of the Ministry of Healthcare of the Moscow Region from September 2024 to March 2025. The patients were divided into 4 groups: the 1st main group consisted of 16 children aged 3 to 8 years, who were prescribed the domestic formula «Protein Detoxification Cocktail NUTRIO» (liquid mixture); the 2nd main group included 16 patients aged 9 to 17 years 11 months who received the domestic product «Detoxifying Protein Cocktail» (dry mixture) or «Detoxifying Protein Cocktail NUTRIO» liquid mixture (optional); the 1st control group included 5 children aged 3 to 8 years who received a formula of an imported manufacturer (liquid mixture) and the 2nd control group included 6 patients aged 9 to 17 years 9 months who received a formula of an imported manufacturer (dry mixture) for 3 months. During the follow-up, the general condition of the children, nutritional status, including anthropometry, caliperometry and bioimpedancemetry, as well as blood parameters and intoxication markers were assessed.
Results: A significant improvement in the physical development of children was shown, in whom malnutrition decreased. This was evidenced by the positive dynamics of body weight, skeletal muscle mass, Z-scores weight/length and body mass index/age, increased blood levels of total protein and albumin. In children taking domestic detox formulas, markers of intoxication significantly decreased, which was reflected in an improvement in the general condition, increased physical activity, endurance, improved quality of life and psycho-emotional state. All patients highly rated the taste of the product. There were no refusals from the product. Allergic, dyspeptic and other side effects were not noted during the follow-up period.
Discussion: The results obtained correlate well with the authors’ data on the study of clinical efficacy, safety and significant economic benefits of using domestic detox formulas.
Conclusion: The use of domestic specialized food products for dietary therapeutic and dietary preventive nutrition «Protein Detoxification Cocktail NUTRIO» and «Protein Detoxification Cocktail» in diet therapy for children with CF is effective for correcting their nutritional status, reducing intoxication and improving the quality of life.
For citations: Odinaeva N.D., Kondratieva E.I., Pilat T.L., Fatkhullina I.R., Zhekaite E.K., Kuznetsova Yu.G. Efficiency of using domestic enteral formula with metabolic action in children with cystic fibrosis. Farmateka. 2025;32(1 suppl. 1):78-86. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2025.1-s1.78-86
Authors’ contribution: Odinaeva N.D. – scientific supervision of the study, editing and final approval of the manuscript. Kondratieva E.I. – study concept and design, editing the manuscript. Pilat T.L. – study concept and design, analysis of the results, writing and editing the manuscript. Fatkhullina I.R., Zhekaite E.K. – collection and processing of material, formation of an electronic database, analysis of the results, writing the text of the article. Kuznetsova Yu.G. – statistical analysis, writing the text of the article.
All authors approved the final version of the article before publication, agreed to be accountable for all aspects of the work, including proper scrutiny and resolution of questions related to the accuracy or integrity of any part of the work.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The study was conducted without any sponsorship.
Ethical Approval: The study protocol was reviewed and approved at a meeting of the Local Independent Ethics Committee at the Research Institute of Childhood of the Ministry of Healthcare of the Moscow Region (minutes of the LEC meeting No. 1 dated 09/18/2024).
Patient Consent for Publication: All patients signed a voluntary informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
Keywords
cystic fibrosis
specialized food product
detoxifying enteral formulas
protein-energy malnutrition
nutritional status
About the Authors
Niso Dz. Odinaeva, Dr. Sci. (Med.), Professor, Director of the Research Clinical Institute of Childhood of the Ministry of Healthcare of the Moscow Region, Mytishchi, Russia; ORCID: https://orcid.org/0000-0001-5214-8072Elena I. Kondratieva, Dr. Sci. (Med.), Professor, Head of the Russian Cystic Fibrosis Center; Head of the Cystic Fibrosis Research and Clinical Department, N.P. Bochkov Medical and Genetic Research Center, Head of the Department of Respiratory Disease Genetics, Institute of Higher and Additional Professional Education, N.P. Bochkov Medical and Genetic Research Center (Moscow); Deputy Director for Science, Research Clinical Institute of Childhood of the Ministry of Healthcare of the Moscow Region, Mytishchi, Russia; ORCID: https://orcid.org/0000-0001-6395-0407
Tatiana L. Pilat, Dr. Sci. (Med.), Professor, Leading Researcher, Izmerov Research Institute of Occupational Medicine, Moscow, Russia; ORCID: https://orcid.org/0000-0002-5930-8849
Irina R. Fatkhullina, Head of the Cystic Fibrosis Department, Research Clinical Institute of Childhood of the Ministry of Healthcare of the Moscow Region, Mytishchi, Russia; ORCID: https://orcid.org/0000-0001-8005-5121
Elena K. Zhekaite, Cand. Sci. (Med.), Senior Researcher of the Cystic Fibrosis Research and Clinical Department, Associate Professor of the Department of Respiratory Disease Genetics, N.P. Bochkov Medical and Genetic Research Center (Moscow); Pediatrician, Cystic Fibrosis Department, Research Clinical Institute of Childhood of the Ministry of Healthcare of the Moscow Region, Mytishchi, Russia; ORCID: https://orcid.org/0000-0001-5013-3360
Yulia G. Kuznetsova, Cand. Sci. (Med.), Assistant Professor, Department of Gastroenterology, Central State Medical Academy of the Administrative Directorate of the President of the Russian Federation, Moscow, Russia; Julia_alina777@mail.ru, ORCID: https://orcid.org/0000-0002-0947-2333 (corresponding author)
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