Effects of Probiotic in Treatment of Persistent Diarrhea in Children
Effects of Probiotic in Treatment of Persistent Diarrhea in Children
NCT ID: NCT05812820 Phase: NA Status: COMPLETED Enrollment: 165 Completion: 2024-11-25
Conditions
Diarrhea
Interventions
LiveSpo DIA30, LiveSpo CLAUSY, RO
Summary
Persistent diarrhea is a common health problem worldwide, particularly in low-income countries. Approximately 3% to 20% of acute diarrhea episodes in children under 5 years of age become persistent diarrhea. Persistent diarrhea causes malnutrition, weight loss, and dehydration, as well as increasing treatment costs and the risk of mortality. One of the main causes of persistent diarrhea is the overgrowth and spread of bacteria, as well as viral infections that can disrupt the balance of microorganisms in the gut. Antibiotics are effective in treating bacterial infections that cause persistent diarrhea in children, but not against viral or parasitic infections. Overuse of antibiotics can lead to the growth of antibiotic-resistant bacteria, which poses a significant public health concern. Probiotics play a vital role in maintaining a healthy balance. Bacillus probiotic strains have an advantage over Lactobacillus probiotics as they can form spores that resist environmental stressors like heat, acid, and bile. This makes them more likely to survive the harsh conditions of the digestive tract and provide health benefits by reaching the intestines intact. Here, the investigators propose high-dose Bacillus spore probiotic supplementation as a potential solution for treating patients with persistent diarrhea.
The aim of the study is to assess the efficacy of two types of Bacillus probiotics which conclude LiveSpo CLAUSY (2 billion B. clausii) and LiveSpo DIA 30 (5 billion B. subtilis, B. clausii and B. coagulans) in supporting the treatment of children with persistent diarrhea.
Study Population: sample size is 150 patients and 30 healthy children. The study is carried out at Vietnam National Children's Hospital.
Description of Study Intervention: Totally 150 eligible patients are divided randomly into 3 groups (n = 50/group each): Patients in the Control group received the routine treatment and 2-3 times/day RO water while the patients in the probiotics group received 2
Primary Outcome
Changes in days of treatment for typical symptoms of persistent diarrhea