Evaluating the Effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS Spore Probiotics in Supporting the Reduction of Constipation, Anorexia, and Slow Weight Gain in Children Aged 24-60 Months

Detailed Summary

Constipation is rising globally and is a health concern in Asia. Prolonged constipation, without proper care, can lead to complications affecting a child's physical and psychological development, causing significant health and socioeconomic impacts. Anorexia is also common in children, affecting their nutrient absorption, weight gain, and height development. Anorexic children are 2.5-3 times more likely to suffer from underweight and stunting. A number of studies have suggested that probiotics can reduce stool retention time and improve stool consistency, making them a natural and safe option for relieving constipation in adults and children. Probiotics, particularly spore-forming probiotics like Bacillus clausii, Bacillus subtilis, and Bacillus coagulans, have shown promise in improving gut health and combating anorexia, constipation, and malnutrition. With this background, the investigators conduct a research project titled "Evaluating the effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS in supporting the reduction of constipation, anorexia, and slow weight gain in children aged 24-60 months". The study aims to: (i) Evaluate the effectiveness of LiveSpo® Preg-Mom and LiveSpo® KIDS in reducing constipation, anorexia, and slow weight gain in children. (ii) Assessing the impact of probiotic supplementation on pro-inflammatory/anti-inflammatory cytokines concentrations in the blood, IgA concentrations in stools, and changes in the intestinal microbiota composition in the children's stools. Study Population: The sample size for aims is 201. Description of Sites: the study is conducted at three communes in Vo Nhai district, Thai Nguyen province. Description of Study Intervention: 201 eligible children aged 24-60 months with signs of anorexia, constipation, and meeting nutritional criteria were selected. The selected children are randomly assigned to three experiment groups, with 67 children per group. Blood samples are taken (at the start and after 28 days of intervention), and fecal samples are collected at the beginning of the study day, day 7, and day 28 of intervention, to analyze cytokine, IgA concentrations, and the gut microbiota. The intervention products are labeled with three codes corresponding to the three experiment groups (For example AA code is used for LiveSpo® Preg-Mom, BB code for LiveSpo® KIDS, CC for code for RO water) and these codes can be interchanged as needed. Study duration: 12 months

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