Promising clinical and immunological efficacy of Bacillus clausii spore probiotics for supportive treatment of persistent diarrhea in children.

Autor: Dang HT; Department of Gastroenterology, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Tran DM; Department of Surgical Intensive Care Unit, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Phung TTB; Department of Molecular Biology for Infectious Diseases, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Bui ATP; Spobiotic Research Center, ANABIO R&D Ltd. Company, No. 22, Lot 7,8 Van Khe Urban, La Khe, Ha Dong, Hanoi, Vietnam., Vu YH; Department of Gastroenterology, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Luong MT; Department of Gastroenterology, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Nguyen HM; Department of Molecular Biology for Infectious Diseases, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Trinh HT; Department of Molecular Biology for Infectious Diseases, Vietnam National Children's Hospital, No. 18/879 La Thanh, Dong Da, Hanoi, Vietnam., Nguyen TT; Spobiotic Research Center, ANABIO R&D Ltd. Company, No. 22, Lot 7,8 Van Khe Urban, La Khe, Ha Dong, Hanoi, Vietnam., Nguyen AH; Spobiotic Research Center, ANABIO R&D Ltd. Company, No. 22, Lot 7,8 Van Khe Urban, La Khe, Ha Dong, Hanoi, Vietnam. nguyenhoaanhbio@gmail.com.; LiveSpo Pharma Ltd. Company, N03T5, Ngoai Giao Doan Urban, Bac Tu Liem, Hanoi, Vietnam. nguyenhoaanhbio@gmail.com., Van Nguyen AT; Spobiotic Research Center, ANABIO R&D Ltd. Company, No. 22, Lot 7,8 Van Khe Urban, La Khe, Ha Dong, Hanoi, Vietnam. vananhbiolab@gmail.com.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2024 Mar 18; Vol. 14 (1), pp. 6422. Date of Electronic Publication: 2024 Mar 18.
DOI: 10.1038/s41598-024-56627-9
Abstrakt: Persistent diarrhea is a severe gastroenteric disease with relatively high risk of pediatric mortality in developing countries. We conducted a randomized, double-blind, controlled clinical trial to evaluate the efficacy of liquid-form Bacillus clausii spore probiotics (LiveSpo CLAUSY; 2 billion CFU/5 mL ampoule) at high dosages of 4-6 ampoules a day in supporting treatment of children with persistent diarrhea. Our findings showed that B. clausii spores significantly improved treatment outcomes, resulting in a 2-day shorter recovery period (p < 0.05) and a 1.5-1.6 folds greater efficacy in reducing diarrhea symptoms, such as high frequency of bowel movement of ≥ 3 stools a day, presence of fecal mucus, and diapered infant stool scale types 4-5B. LiveSpo CLAUSY supportive treatment achieved 3 days (p < 0.0001) faster recovery from diarrhea disease, with 1.6-fold improved treatment efficacy. At day 5 of treatment, a significant decrease in blood levels of pro-inflammatory cytokines TNF-α, IL-17, and IL-23 by 3.24% (p = 0.0409), 29.76% (p = 0.0001), and 10.87% (p = 0.0036), respectively, was observed in the Clausy group. Simultaneously, there was a significant 37.97% decrease (p = 0.0326) in the excreted IgA in stool at day 5 in the Clausy group. Overall, the clinical study demonstrates the efficacy of B. clausii spores (LiveSpo CLAUSY) as an effective symptomatic treatment and immunomodulatory agent for persistent diarrhea in children.Trial registration: NCT05812820.
(© 2024. The Author(s).)
Databáze: MEDLINE
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