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

Not Applicable

Completed

• Conditions: Elevated Blood Lead Levels
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus plantarum DSM 33464

• Registration Number: NCT04891666
• Lead Sponsor: Novozymes A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Study Start: 2021-07-06
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks
Lactobacillus plantarum DSM 33464	Lactobacillus plantarum DSM 33464	1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Reduction of blood lead levels	12 weeks	Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline

Secondary Outcome Measures

Name	Time	Method
Reduction of blood lead levels	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
Reduction of urine lead levels	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
Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood	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

Trial Locations

Locations (5)

Baoding children's hospital; 🇨🇳 Baoding, Hebei, China

Children's Hospital of Heibei Province; 🇨🇳 Shijiazhuang, Hebei, China

Beijing Children's Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Chengdu women's and children's Central Hospital; 🇨🇳 Chengdu, Sichuan, China

Xuzhou children's Hospital; 🇨🇳 Xuzhou, Jiangsu, China