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

NCT04891666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-07-14

No results posted yet for this study

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.

Conditions

  • Elevated Blood Lead Levels

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum DSM 33464

1 sachet SmartGuard® per day for 12 weeks

DIETARY_SUPPLEMENT

Placebo

1 sachet of placebo per day for 12 weeks

Sponsors & Collaborators

  • Beijing Children's Hospital

    collaborator OTHER

  • Baoding Children's Hospital

    collaborator OTHER

  • Xuzhou Children Hospital

    collaborator OTHER

  • Chengdu Women's and Children's Central Hospital

    collaborator OTHER

  • Children's Hospital of Heibei Province

    collaborator UNKNOWN

  • Beijing Clinical Service Center

    collaborator OTHER

  • Novozymes A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-03-17
Completion
2023-03-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891666 on ClinicalTrials.gov