Effectiveness of Bacillus Spore Probiotics in Reducing Constipation, Anorexia, and Slow Weight Gain in Children

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

Conditions

• Constipation
• Anorexia
• Weight Gain

Interventions

OTHER

RO water

Aquafina's reverse osmosis (RO) water, produced by PepsiCo, have both obtained ISO 9001:2015 and ISO 22000:2018 certifications, which are internationally recognized standards for quality management and food safety management systems, respectively. The RO water ampoules are produced using a similar process as the LIVESPO Preg-Mom/ KIDS but contain 5ml of high-quality RO water from Aquafina (proper noun)

DIETARY_SUPPLEMENT

LiveSpo Preg-Mom

LiveSpo® Preg-Mom has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

DIETARY_SUPPLEMENT

LiveSpo KIDS

LiveSpo® KIDS has a registration number 1537/2023/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

Sponsors & Collaborators

• National Institute of Nutrition, Vietnam

  collaborator OTHER_GOV

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Hanh TL Nguyen, PhD · National Institute of Nutrition (NIN), Ministry of Health, Vietnam

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

24 Months

Max Age

60 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-10

Primary Completion

2024-04-07

Completion

2024-09-30

Countries

• Vietnam

Study Locations