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Completed

NCT Number: NCT04891666

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

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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Key information

Conditions

Elevated Blood Lead Levels

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Children's Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus plantarum DSM 33464

Dietary Supplement

1 sachet SmartGuard® per day for 12 weeks

Other names: SmartGuard®

Placebo

Dietary Supplement

1 sachet of placebo per day for 12 weeks

Primary outcomes

  1. 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

  1. Reduction of blood lead levels

    Time frame: 4 and 8 weeks

    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

  2. Reduction of urine lead levels

    Time frame: 4, 8 and 12 weeks

    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

  3. Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood

    Time frame: 4, 8 and 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Novozymes A/S

Industry

Collaborators

  • Baoding Children's Hospital
  • Beijing Children's Hospital
  • Beijing Clinical Service Center
  • Chengdu Women's and Children's Central Hospital
  • Children's Hospital of Hebei Province
  • Xuzhou Children Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 18, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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