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

A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) 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.

Study Overview

• Status: Completed
• Conditions: Elevated Blood Lead Levels
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum DSM 33464; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenqian Gu; Phone Number: +4530770423; Email: wqg@novozymes.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
  • Hebei
    • Baoding, Hebei, China
      • Baoding children's hospital
    • Shijiazhuang, Hebei, China
      • Children's Hospital of Heibei Province
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Xuzhou Children's Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Women's and Children's Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The subjects who meet all of the following selection criteria can participate in this study:

1. Children age 3-12 years
2. BLL 35-249 µg/L
3. Subjects, their parents or legal guardians are able and willing to comply with research guidance
4. 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:

1. 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;
2. History of infection or organ transplantation of human immunodeficiency virus or other acquired congenital immunodeficiency diseases;
3. Take probiotic products in the last two weeks
4. Known or suspected sensitivity or allergy to food or any constituents tested in the trial
5. Participation in another clinical trial or food study 4 weeks prior and during the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus plantarum DSM 33464; 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; 1 sachet SmartGuard® per day for 12 weeks; Other Names: SmartGuard®
Placebo Comparator: placebo; 1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks	Dietary supplement: Placebo; 1 sachet of placebo per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of blood lead levels	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	4 and 8 weeks
Reduction of urine lead levels	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	4, 8 and 12 weeks
Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood	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	4, 8 and 12 weeks

Collaborators and Investigators

• Sponsor: Novozymes A/S
• Collaborators: Beijing Children's Hospital; Chengdu Women's and Children's Central Hospital; Beijing Clinical Service Center; Baoding Children's Hospital; Xuzhou Children's Hospital; Children's Hospital of Heibei Province

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NZ-GHSG-2020-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No