Status:
COMPLETED
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children
Lead Sponsor:
Novozymes A/S
Collaborating Sponsors:
Beijing Children's Hospital
Baoding Children's Hospital
Conditions:
Elevated Blood Lead Levels
Eligibility:
All Genders
3-12 years
Phase:
NA
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-be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subjects who meet any of the following exclusion criteria may not participate in this study:
- 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
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04891666
Start Date
July 6 2021
End Date
March 17 2023
Last Update
July 14 2023
Active Locations (5)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Baoding children's hospital
Baoding, Hebei, China
3
Children's Hospital of Heibei Province
Shijiazhuang, Hebei, China
4
Xuzhou children's Hospital
Xuzhou, Jiangsu, China