APPLICATION OF THE SACCHAROMYCES BOULARDII PROBIOTIC COMPLEX IN THE CORRECTION OF INTRAINTESTINAL HOMEOSTASIS IN PATIENTS WITH DYSBIOTIC DISORDERS DUE TO ANTIBIOTIC THERAPY

The aim: Evaluation of the effectiveness of the biotherapeutic agent Saccharomyces boulardii in the treatment complex of patients with clinical manifestations of dysbiosis and/or signs of enteric insufficiency refractory to previous therapy, to develop ways for their medical correction. Materials and methods: The study included 209 patients, treated during 2018-2020, grouped into main and the comparison group. The main group was divided into subgroups depending on the nosological form of the underlying disease: surgical – 36, general therapeutic – 58, gynecological – 47 patients. Main group treatment was supplemented with Saccharomyces boulardii for 10-14 days from the first day of inclusion of patients in the observation group. Results: The analysis of motor-evacuation disorders verified flatulence in 89.47%, localized epigastric pain in 22.48%, diarrhea in 55.02%, and constipation in 11.48% of cases. Based on the results of laboratory parameters, an absolute increase in the number of leukocytes in the range from 12.4 ± 1.8 x 109 / l to 14.7 ± 2.8 x 109 / l with a neutrophilic formula shift, bilirubinemia to 54.4 ± 12.2 mmol / l , elevated levels of urea to 14.7 ± 3.9 and creatinine to 0.199 ± 0.07 mmol / L. Conclusions: After completion of the treatment course (main group), a significant (p <0.05) improvement in the general condition (decrease in stool frequency within 1–4 times (2.3 ± 0.28) per day, the absence of rumbling, flatulence and pain in abdomen) in 131 (92.9%) of 141 patients included in the study was stated. Clinical improvement was confirmed by bacteriological studies of copro-culture.

Safety and Efficacy of Saccharomyces boulardii for the management of Diarrhoea in Indian children

Objective: S. boulardii seem to be an assuring biotherapeutic agent for the amelioration of the course of diarrhoea in children when used therapeutically. S. boulardii mediates responses resembling the protective effects of the normal healthy gut flora. Our objective was to access the safety and efficacy of S. boulardii on childhood diarrhea. Methodology: Total 210 patients were enrolled out of which 184 patients completed the study S. boulardii sachets (5 million CFU~282.5mg) were given to the patients enrolled in the study. Efficacy and safety assessment was made by quantitating the Frequency, Intensity and Consistency of stools. Results: Stool frequency decreased from 9.005 to 2.7 at the end of 5 days. Severity scale was extrapolated which interestingly showed zero patients with severe diarrhoea. There was a reduction in the duration of diarrhoea along with stool consistency where in majority patients with watery stool came down to 2 from 136. Conclusions: Saccharomyces boulardii is safe and efficacious in the treatment of diarrhoea in Indian children

Physicochemical Characteristics of Transferon™Batches

Transferon, a biotherapeutic agent that has been used for the past 2 decades for diseases with an inflammatory component, has been approved by regulatory authorities in Mexico (COFEPRIS) for the treatment of patients with herpes infection. The active pharmaceutical ingredient (API) of Transferon is based on polydispersion of peptides that have been extracted from lysed human leukocytes by a dialysis process and a subsequent ultrafiltration step to select molecules below 10 kDa. To physicochemically characterize the drug product, we developed chromatographic methods and an SDS-PAGE approach to analyze the composition and the overall variability of Transferon. Reversed-phase chromatographic profiles of peptide populations demonstrated batch-to-batch consistency from 10 representative batches that harbored 4 primary peaks with a relative standard deviation (RSD) of less than 7%. Aminogram profiles exhibited 17 proteinogenic amino acids and showed that glycine was the most abundant amino acid, with a relative content of approximately 18%. Further, based on their electrophoretic migration, the peptide populations exhibited a molecular mass of about 10 kDa. Finally, we determined the Transferon fingerprint using a mass spectrometry tool. Because each batch was produced from independent pooled buffy coat samples from healthy donors, supplied by a local blood bank, our results support the consistency of the production of Transferon and reveal its peptide identity with regard to its physicochemical attributes.