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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
| Baoding Children's Hospital | OTHER |
| Xuzhou Children Hospital | OTHER |
| Chengdu Women's and Children's Central Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus plantarum DSM 33464 | Experimental | 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks |
|
| placebo | Placebo Comparator | 1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum DSM 33464 | Dietary Supplement | 1 sachet SmartGuardĀ® per day for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
The subjects who meet all of the following selection criteria can participate in this study:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria may not participate in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | Beijing Municipality | 100045 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40959702 | Derived | Ji W, Saulnier DM, Zhang L, Liu J, Gao J, Wang X, Holz C, Liang A, Tan HT. Effects of Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels: a randomized, double-blind, placebo-controlled study. Front Nutr. 2025 Sep 1;12:1641839. doi: 10.3389/fnut.2025.1641839. eCollection 2025. |
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| OTHER |
| Children's Hospital of Hebei Province | OTHER |
| Beijing Clinical Service Center | OTHER |
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| Placebo | Dietary Supplement | 1 sachet of placebo per day for 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
| 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 |
| Baoding children's hospital |
| Baoding |
| Hebei |
| China |
| Children's Hospital of Heibei Province | Shijiazhuang | Hebei | China |
| Xuzhou children's Hospital | Xuzhou | Jiangsu | China |
| Chengdu women's and children's Central Hospital | Chengdu | Sichuan | China |