Completed

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

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What is being tested

RO water

+ LiveSpo Preg-Mom

+ LiveSpo KIDS

OtherDietary Supplement
Who is being recruted

Anorexia+5

+ Body Weight

+ Body Weight Changes

From 24 to 60 Months
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorAnabio R&D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 10, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness of two probiotic products, LiveSpo® Preg-Mom and LiveSpo® KIDS, in helping children aged 24 to 60 months who experience constipation, anorexia, and slow weight gain. These conditions are significant concerns as they can affect a child's growth and development. Probiotics, which are beneficial bacteria, are being explored because they might help improve digestive health and nutrient absorption in children. The study aims to determine if these probiotics can alleviate symptoms and improve overall well-being in affected children, which could lead to better health outcomes and quality of life. The clinical trial involves 201 children who are randomly divided into three groups. One group receives LiveSpo® Preg-Mom, another receives LiveSpo® KIDS, and the third group acts as a control, receiving only water. Each child takes two doses of their assigned product every day. Researchers assess the children's health by observing changes in weight, stool quality, and eating habits over 28 days. They also conduct blood and stool tests to measure changes in immune markers and bacterial balance in the gut. The study is designed to ensure reliable results by using advanced techniques and statistical analyses to compare the effects of the probiotics against the control group.

Official TitleEvaluating 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
NCT06154525
Principal SponsorAnabio R&D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 24 to 60 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnorexiaBody WeightBody Weight ChangesConstipationSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsWeight Gain

Criteria

5 inclusion criteria required to participate
Children aged 24-60 months.
Children diagnosed with loss of appetite and/or constipation and/or diarrhea.
Have a weight-for-age Z-score between -1 and -3.
Children are fed via the digestive system and have been weaned from breastfeeding.
Show More Criteria
7 exclusion criteria prevent from participating
Parents or guardians who do not consent to participate in the research or do not comply with the research procedures
Children outside the age range of 24-60 months
Severely malnourished children with WAZ-Score > 3, HAZ-Score > 3.
Currently suffering from acute infectious diseases such as pneumonia, acute diarrhea, liver or kidney disorders, etc.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
The control group receives RO water with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Group II

Experimental
The Preg-Mom group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5 mL (LiveSpo® Preg-Mom) with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Group III

Experimental
The KIDS group receives RO water plus B. subtilis and B. clausii at 3 billion CFU/5 mL (LiveSpo® KIDS) with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institute of Nutrition

Hanoi, VietnamOpen National Institute of Nutrition in Google Maps
CompletedOne Study Center