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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-03-17

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.

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Detailed Description

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Conditions

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Elevated Blood Lead Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactobacillus plantarum DSM 33464

1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks

Group Type EXPERIMENTAL

Lactobacillus plantarum DSM 33464

Intervention Type DIETARY_SUPPLEMENT

1 sachet SmartGuard® per day for 12 weeks

placebo

1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 sachet of placebo per day for 12 weeks

Interventions

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Lactobacillus plantarum DSM 33464

1 sachet SmartGuard® per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 sachet of placebo per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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SmartGuard®

Eligibility Criteria

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Inclusion Criteria

The subjects who meet all of the following selection criteria can participate in this study:

1. Children age 3-12 years
2. BLL 35-249 µg/L
3. Subjects, their parents or legal guardians are able and willing to comply with research guidance
4. Subject's parents or legal guardians sign written informed consent.

Exclusion Criteria

1. 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;
2. History of infection or organ transplantation of human immunodeficiency virus or other acquired congenital immunodeficiency diseases;
3. Take probiotic products in the last two weeks
4. Known or suspected sensitivity or allergy to food or any constituents tested in the trial
5. Participation in another clinical trial or food study 4 weeks prior and during the trial

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No