Effectiveness of Bacillus Spore Probiotics in Reducing Constipation, Anorexia, and Slow Weight Gain in Children
Effectiveness of Bacillus Spore Probiotics in Reducing Constipation, Anorexia, and Slow Weight Gain in Children
NCT ID: NCT06154525 Phase: NA Status: COMPLETED Enrollment: 201 Completion: 2024-09-30
Conditions
Constipation, Anorexia, Weight Gain
Interventions
RO water, LiveSpo Preg-Mom, LiveSpo KIDS
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
Primary Outcome
Changes in the frequency of bowel movements per week