CompletedNot Applicable

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

China66 participantsStarted 2021-07-06

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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

What they're measuring

Reduction of blood lead levels

Timeframe: 12 weeks

Trial details

NCT IDNCT04891666

SponsorNovozymes A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-17

View on ClinicalTrials.gov More Elevated Blood Lead Levels trials