Evaluate the safety and effectiveness of Bacillus probiotic spores in children with persistent diarrhea
Authors:   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Dang Thuy Ha , Tran Minh Dien ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Phung T hi Bich Thuy ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Nguyen Thi Viet Ha ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Bui Thi Phuong Anh ,   ANABIO R&D Company Limited, 22 Lot 7+8 Van Khe Urban Area, La Khe Ward, Ha Dong District, Hanoi, Vietnam, Vu Hai Yen ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Luong Thi Minh ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Nguyen Thi Thu Trang ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Pham Thi Thanh Nga ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Nguyen Thi Ngoc Hong ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Le Thi Huong ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Nguyen Van Ngoan ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Nguyen Minh Hang ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Trinh Thi Huong ,   Vietnam National Children's Hospital, 8/879 La Thanh Street, Lang Thuong Ward, Dong Da District, Hanoi, Vietnam, Bui Thi Huyen ,   ANABIO R&D Company Limited, 22 Lot 7+8 Van Khe Urban Area, La Khe Ward, Ha Dong District, Hanoi, Vietnam, Vo Thi Ngoc Hao ,   ANABIO R&D Company Limited, 22 Lot 7+8 Van Khe Urban Area, La Khe Ward, Ha Dong District, Hanoi, Vietnam, Nguyen Hoa Anh ,   ANABIO R&D Company Limited, 22 Lot 7+8 Van Khe Urban Area, La Khe Ward, Ha Dong District, Hanoi, Vietnam,   LiveSpo Pharma Company Limited, N03 T5 Ngoai Giao Doan, Xuan Tao Ward, Bac Tu Liem District, Hanoi, Vietnam, Nguyen Thi Van Anh ,   ANABIO R&D Company Limited, 22 Lot 7+8 Van Khe Urban Area, La Khe Ward, Ha Dong District, Hanoi, Vietnam
Published: June 2024

Persistent diarrhea in children under 24 months old has been a global public health concern, including in Vietnam. Therefore, the authors conducted a randomised, double-blind, placebo-controlled clinical trial to evaluate the effectiveness of two Bacillus spore probiotic suspensions, namely LiveSpo CLAUSY containing B. clausii at 2 billion CFU/5 ml ampoule; and LiveSpo DIA30 containing B. subtilis, B. clausii, and B. coagulans at 5 billion CFU/5 ml ampoule, as a supportive treatment for children with persistent diarrhea. Children were randomly allocated into the control (using RO water) and two experimental groups, Clausy (using LiveSpo CLAUSY) and Dia30 (using LiveSpo DIA30), n=30/group. All three groups were treated following the standard protocol at the hospital, supplemented with either placebo or high-dose probiotics up to 4-6 ampoules/day. The results showed that Bacillus spore probiotics helped to shorten the treatment duration by approximately 1-3 days and enhanced treatment effectiveness by 1.3-2.4 folds compared to the control group in reducing the typical diarrhea symptoms, including bowel movements ≥3 times/day, presence of mucus, and diaper stool. Notably, LiveSpo DIA30 exhibited a better efficacy of 10-50% compared to LiveSpo CLAUSY. This is the world’s first clinical study demonstrating the effectiveness of high-dose Bacillus spore probiotics in supporting the treatment of diarrhea symptoms in children with persistent diarrhea.