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

Novozymes A/S5 sites in 1 country66 target enrollmentJuly 6, 2021

ConditionsElevated Blood Lead Levels

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Elevated Blood Lead Levels
Sponsor: Novozymes A/S
Enrollment: 66
Locations: 5
Primary Endpoint: Reduction of blood lead levels
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2021

End Date

March 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novozymes A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reduction of blood lead levels

Time Frame: 12 weeks

Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline

Secondary Outcomes

Reduction of blood lead levels(4 and 8 weeks)
Reduction of urine lead levels(4, 8 and 12 weeks)
Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood(4, 8 and 12 weeks)