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

Elevated Blood Lead Levels Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891666
• Other study ID #: NZ-GHSG-2020-02
• Status: Completed
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: March 17, 2023

Study information

• Verified date: July 2023
• Source: Novozymes A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Lead Levels

Intervention

Dietary Supplement:
• Lactobacillus plantarum DSM 33464
1 sachet SmartGuard® per day for 12 weeks
• Placebo
1 sachet of placebo per day for 12 weeks

Locations

Country	Name	City	State
China	Baoding children's hospital	Baoding	Hebei
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	Chengdu women's and children's Central Hospital	Chengdu	Sichuan
China	Children's Hospital of Heibei Province	Shijiazhuang	Hebei
China	Xuzhou children's Hospital	Xuzhou	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
Novozymes A/S	Baoding Children's Hospital, Beijing Children's Hospital, Beijing Clinical Service Center, Chengdu Women's and Children's Central Hospital, Children's Hospital of Heibei Province, Xuzhou Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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