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Microbial characterization of the Japanese traditional pickle senmaizuke produced by two different manufacturing processes.

ABSTRACT: Senmaizuke, a traditional turnip pickle, prepared in Kyoto, Japan, is produced via two types of manufacturing processes: with and without vinegar for fermentation. The aim of this study was to reveal the microbial community and growth behavior in the products and manufacturing processes of two types of senmaizuke. Microbial growth analysis of commercial senmaizuke products showed that both types harbored 10²-10⁸ colony forming units (CFU)/g of lactic acid bacteria (LAB) and 10²-10⁴ of yeast. The fermented-type products showed successive growth of LAB during the pickling and ripening processes, whereas LAB in vinegar-type products showed growth only at the preliminary pickling step before vinegar addition; however, the bacteria were viable at the ripening step. LAB in the vinegar-type products showed growth when the pH of the pickle was neutralized, indicating that acidification via vinegar retards LAB growth. Metagenomic sequencing showed that the fermented-type products harbored Lactobacillus, Leuconostoc, and other halophilic and psychrophilic bacteria, with a higher bacterial diversity than in the vinegar-type products. In the vinegar-type products, Lactobacillus, Leuconostoc, or both were predominant. Culture tests using LAB isolates and turnip medium suggested that a change in the dominance of Leuconostoc to Lactobacillus members observed in the fermented-type products during pickling and ripening processes was attributed to the low pH sensitivity of Leuconostoc as well as a relatively long lag phase of growth for adapting to the pickling environment. The findings of this study will be useful for the appropriate quality control and assurance procedure of senmaizuke.

SUBMITTER: Iguchi H

PROVIDER: S-EPMC8358362 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Cetuximab, in combination with platinum chemotherapy plus 5-fluoruracil (5-FU), is approved for the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab manufactured by ImClone (US commercial cetuximab) potentially results in higher systemic exposures than cetuximab manufactured by Boehringer Ingelheim (BI-manufactured cetuximab). This prospective, randomized, double-blind study compared the safety profiles of the two cetuximab formulations. METHODS:Patients with previously untreated locoregionally recurrent and/or metastatic SCCHN were randomly assigned to receive the same dose of US commercial cetuximab (Arm A) or BI-manufactured cetuximab (Arm B), each in combination with cisplatin or carboplatin plus 5-FU. The primary outcome was all-grade, all-cause treatment-emergent adverse events (TEAEs). RESULTS:The majority of patients experienced ? 1 TEAE, regardless of causality (Arm A: 75/77 patients, 97.4%; Arm B: 68/71 patients, 95.8%). TEAEs with the highest incidence included nausea, fatigue, and hypomagnesemia in both arms. The absolute risk difference between the two arms for patients experiencing at least one adverse event (AE) was 0.029 (p = 0.281, 95% confidence interval [CI]: -0.024, 0.082) for AEs regardless of causality and 0.005 (p = 0.915, 95% CI: -0.092, 0.103) for AEs possibly related to study drug. There were no significant differences between the two arms in the incidence of acneiform rash, cardiac events, infusion reactions, or hypomagnesemia. Overall survival, progression-free survival, and overall response rates were similar in the two arms. CONCLUSIONS:There were no clinically meaningful differences in safety between US commercial cetuximab and BI-manufactured cetuximab in combination with platinum-based therapy with 5-FU in patients with locoregionally recurrent and/or metastatic SCCHN. The use of US commercial cetuximab in this combination chemotherapy regimen did not result in any unexpected safety signals. The efficacy results of this study are consistent with the efficacy results of the cetuximab arm of the EXTREME study. TRIAL REGISTRATION:ClinicalTrials.gov NCT01081041 ; date of registration: March 3, 2010).

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Microbial characterization of the Japanese traditional pickle senmaizuke produced by two different manufacturing processes.

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