NCT04891666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

May 13, 2021

Last Update Submit

July 12, 2023

Conditions

Elevated Blood Lead Levels

Outcome Measures

Primary Outcomes (1)

  • Reduction of blood lead levels

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

    12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Lactobacillus plantarum DSM 33464

EXPERIMENTAL

1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks

Dietary Supplement: Lactobacillus plantarum DSM 33464

placebo

PLACEBO COMPARATOR

1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum DSM 33464DIETARY_SUPPLEMENT

1 sachet SmartGuard® per day for 12 weeks

Also known as: SmartGuard®
Lactobacillus plantarum DSM 33464
PlaceboDIETARY_SUPPLEMENT

1 sachet of placebo per day for 12 weeks

placebo

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Baoding children's hospital

Baoding, Hebei, China

Location

Children's Hospital of Heibei Province

Shijiazhuang, Hebei, China

Location

Xuzhou children's Hospital

Xuzhou, Jiangsu, China

Location

Chengdu women's and children's Central Hospital

Chengdu, Sichuan, China

Location

Related Publications (1)

  • Ji W, Saulnier DM, Zhang L, Liu J, Gao J, Wang X, Holz C, Liang A, Tan HT. Effects of Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels: a randomized, double-blind, placebo-controlled study. Front Nutr. 2025 Sep 1;12:1641839. doi: 10.3389/fnut.2025.1641839. eCollection 2025.

    PMID: 40959702DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

July 6, 2021

Primary Completion

March 17, 2023

Study Completion

March 17, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)