A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children

Study Overview
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Brief Summary
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The study is a parallel, randomized, double-blind, placebo controlled clinical trial will evaluate the effect of Lactobacillus plantarum DSM 33464 on reduction of Blood lead levels and general well-being of children.

Official Title
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A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children

Conditions
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Elevated Blood Lead Levels

Intervention / Treatment
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* Dietary Supplement: Lactobacillus plantarum DSM 33464
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects who meet all of the following selection criteria can participate in this study: Children age 3-12 years BLL 35-249 µg/L Subjects, their parents or legal guardians are able and willing to comply with research guidance Subject's parents or legal guardians sign written informed consent. Exclusion Criteria: Subjects who meet any of the following exclusion criteria may not participate in this study: Diagnosed with nervous system diseases, genetic and metabolic diseases, endocrine diseases, lung diseases, severe or unstable cardiovascular diseases, clinically significant kidney or liver diseases, blood system diseases, any other clinically significant diseases and Other investigators judge that the participation of subjects in the study will increase the risk of the subjects' diseases; History of infection or organ transplantation of human immunodeficiency virus or other acquired congenital immunodeficiency diseases; Take probiotic products in the last two weeks Known or suspected sensitivity or allergy to food or any constituents tested in the trial Participation in another clinical trial or food study 4 weeks prior and during the trial

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus plantarum DSM 33464<br>1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks | Dietary Supplement: Lactobacillus plantarum DSM 33464<br>* 1 sachet SmartGuard® per day for 12 weeks<br>* Other names: SmartGuard®;|
| Placebo Comparator: placebo<br>1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks | Dietary Supplement: Placebo<br>* 1 sachet of placebo per day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of blood lead levels | Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of blood lead levels | Compared with the baseline, the difference between the reduction of the blood lead level in the experimental group and the placebo group at the 4th and 8th week | 4 and 8 weeks | 
| Reduction of urine lead levels | Compared with baseline, the difference between the reduction of urine lead levels in the experimental group and the placebo group at the 4th, 8th, and 12th week | 4, 8 and 12 weeks | 
| Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood | Compared with baseline, the difference between the improvement of common trace elements Ca,Zn,Cu,Mg,Fe in the blood of the experimental group and the placebo group at the 4th, 12th and 24th week | 4, 8 and 12 weeks |