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

N

Novozymes

Status

Completed

Conditions

Elevated Blood Lead Levels

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus plantarum DSM 33464

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04891666
NZ-GHSG-2020-02

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 2 patient groups, including a placebo group

Lactobacillus plantarum DSM 33464
Experimental group
Description:
1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks
Treatment:
Dietary Supplement: Lactobacillus plantarum DSM 33464
placebo
Placebo Comparator group
Description:
1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Central trial contact

Wenqian Gu

Data sourced from clinicaltrials.gov

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