Elevated Blood Lead LevelsNCT04891666
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children
A study testing Lactobacillus plantarum DSM 33464 in people with Elevated Blood Lead Levels, run by Novozymes A/S at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Elevated Blood Lead Levels
- What is being tested?
- Lactobacillus plantarum DSM 33464
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 5 sitesChina
- Study dates
- 6 Jul 2021to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Baoding children's hospital
Baoding, Hebei
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Chengdu women's and children's Central Hospital
Chengdu, Sichuan
Children's Hospital of Heibei Province
Shijiazhuang, Hebei
Xuzhou children's Hospital
Xuzhou, Jiangsu
About this study
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children
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.
- Conditions
- Elevated Blood Lead Levels
- Being tested
- Lactobacillus plantarum DSM 33464, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum DSM 33464Dietary supplement
Also called SmartGuard®
1 sachet SmartGuard® per day for 12 weeks
PlaceboDietary supplement
1 sachet of placebo per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Lactobacillus plantarum DSM 33464 |
| placebo | Placebo comparator | 1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start6 Jul 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Blood Lead LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Children's Hospital, Baoding Children's Hospital, Xuzhou Children Hospital, Chengdu Women's and Children's Central Hospital, Children's Hospital of Hebei Province, Beijing Clinical Service Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891666
- Sponsor's protocol ID
- NZ-GHSG-2020-02
- Status last verified
- Jul 2023
- First submitted
- 13 May 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40959702
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children
- ClinicalTrials.gov ID
- NCT04891666
- Acronym / sponsor ID
- NZ-GHSG-2020-02
- Conditions
- Elevated Blood Lead Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Children's Hospital, Baoding Children's Hospital, Xuzhou Children Hospital, Chengdu Women's and Children's Central Hospital, Children's Hospital of Hebei Province, Beijing Clinical Service Center
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum DSM 33464 | Experimental | Dietary Supplement: Lactobacillus plantarum DSM 334641 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks |
| placebo | Placebo comparator | Dietary Supplement: Placebo1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum DSM 33464Also: SmartGuard®1 sachet SmartGuard® per day for 12 weeks | Dietary supplement | Lactobacillus plantarum DSM 33464 |
| Placebo1 sachet of placebo per day for 12 weeks | Dietary supplement | placebo |
Primary outcome
Reduction of blood lead levels
Time frame: 12 weeks
Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline
3 secondary outcomes
Reduction of blood lead levels
Time frame: 4 and 8 weeks
Reduction of urine lead levels
Time frame: 4, 8 and 12 weeks
Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood
Time frame: 4, 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Derived from this study: PubMed 40959702Ji 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum DSM 33464 in people with Elevated Blood Lead Levels, run by Novozymes A/S at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of blood lead levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.