Effect of prebiotic and probiotics mixture on bowel movement and gut microflora in children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20160825001

Enrollment

Unknown

Registered

2016-08-25

Start date

2016-02-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal children Gut microflora Prebiotic Probiotic

Interventions

The prebiotic used in this product is chicory inulin (2.24 gram/sachet). Inulin is a soluble dietary fiber and a natural prebiotic. The probiotics used in this product are Lactobacillus acidophilus LA

Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

BIOLIFE A.B. PRE & PRO,Placebo

Eligibility

Sex/Gender

All

Age

2 Years to 4 Years

Inclusion criteria

Inclusion criteria: Normal healthy children age 2 - 4 years

Exclusion criteria

Exclusion criteria: -Any known congenital disease -Immune deficiency -Use of any oral laxative < 4 weeks before enrollment -Mental retardation -Functional constipation -Organic causes of constipation such as Hirschsprungâ€™s disease, spinal bifida, hypothyroidism or other metabolic or renal abnormalities -Use of drugs (e.g. calcium channel blockers, antidysrhythmic agents, anticonvulsants, antidepressants, anticholinergic agents) influencing gastrointestinal function

Design outcomes

Primary

Measure	Time frame
The effect of prebiotic and probiotics mixture on the frequency and consistency of bowel movement 4 weeks Diary record	—

Secondary

Measure	Time frame
The effect of prebiotic and probiotics mixture on the stool bifidobacteria and lactobacillus 4 weeks quantitative PCR	—

Countries

Thailand

Contacts

Public ContactVoranush Chongsrisawat

Faculty of Medicine, Chulalongkorn University

voranush.c@chula.ac.th022564951

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026