NCT06154525

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

Completed NA Last updated 16 October 2024

What this trial tests

NA trial testing RO water in Constipation in 201 participants. Completed in 30 September 2024.

Timeline

10 March 2024

Primary endpoint
7 April 2024

30 September 2024

Quick facts

Lead sponsor	Anabio R&D
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	201
Start date	10 March 2024
Primary completion	7 April 2024
Estimated completion	30 September 2024
Sites	1 location across Vietnam

Drugs / interventions tested

• RO water
• LiveSpo Preg-Mom
• LiveSpo KIDS

Conditions studied

• Constipation — all drugs for Constipation →
• Anorexia — all drugs for Anorexia →
• Weight Gain — all drugs for Weight Gain →

Sponsor

Anabio R&D — full company profile →

Who can join

Adults 24 Months to 60 Months, any sex, with Constipation or Anorexia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bacillus spore probiotics for alleviating functional constipation in children: a randomized, double-blind, placebo-controlled trial.
   Nguyen HTL, Hoang HT, Le DP, Duong TQ, et al · · 2026 · PMID 41851313 · DOI 10.1038/s43856-026-01517-6