Clinical trial NCT04891666: A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Blood Lead Levels
Lead sponsor: Novozymes A/S
Sponsor class: INDUSTRY
Collaborators: name: Beijing Children's Hospital
name: Baoding Children's Hospital
name: Xuzhou Children Hospital
name: Chengdu Women's and Children's Central Hospital
name: Children's Hospital of Heibei Province
name: Beijing Clinical Service Center
First posted: 2021-05-18
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of blood lead levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of blood lead levels
timeFrame: 4 and 8 weeks
measure: Reduction of urine lead levels
timeFrame: 4, 8 and 12 weeks
measure: Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Baoding
country: China
facility: Baoding children's hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Children's Hospital of Heibei Province
state: Hebei
city: Xuzhou
country: China
facility: Xuzhou children's Hospital
state: Jiangsu
city: Chengdu
country: China
facility: Chengdu women's and children's Central Hospital
state: Sichuan
Study officials:
References: