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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
66
1 sachet SmartGuard® per day for 12 weeks
1 sachet of placebo per day for 12 weeks
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Baoding children's hospital
Baoding, Hebei, China
Children's Hospital of Heibei Province
Shijiazhuang, Hebei, China
Xuzhou children's Hospital
Xuzhou, Jiangsu, China
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
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 4, 8 and 12 weeks
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Chengdu women's and children's Central Hospital
Chengdu, Sichuan, China