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

Phase 3

Completed

• Conditions: ormal children; Gut microflora; Prebiotic; Probiotic

• Registration Number: TCTR20160825001
• Lead Sponsor: BiO-LiFE Marketing Sdn. Bhd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-31
• Study Start: 2016-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Normal healthy children age 2 - 4 years

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 Hirschsprung’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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of prebiotic and probiotics mixture on the frequency and consistency of bowel movement 4 weeks Diary record

Secondary Outcome Measures

Name	Time	Method
The effect of prebiotic and probiotics mixture on the stool bifidobacteria and lactobacillus 4 weeks quantitative PCR