Elevated Blood Lead LevelsNCT05507021
Effect of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Young Women of Child-bearing Age
A study testing Lactobacillus plantarum DSM 33464, MegaMetalliQ in people with Elevated Blood Lead Levels, run by Novozymes A/S at 1 site in Mexico.
Trial summary
We hypothesize that Lactobacillus Plantarum DSM 33464 reduce lead levels. Approximately 200 women 18 to 40 will be screened for blood lead levels. From that pool of subjects, 40 healthy women aged 18 to 40 years will participate in this randomized, placebo controlled pilot clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Lead Levels
- What is being tested?
- Lactobacillus plantarum DSM 33464, MegaMetalliQ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteMexico
- Study dates
- 31 Oct 2022to 12 Apr 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 40 years old.
- Women with capillary blood Pb levels between 3.3 µg/dL (Lead Care detection limit) and 25 µg/dL.
- Residents of Santa Fe, Mexico City.
- Women of childbearing age, using the same contraceptive method (any) since at least 3 cycles before the start of the study and who agree to maintain it for the entire duration of the study.
- Women who give their informed consent in writing.
Who cannot join
- Women with a diagnosed history of diseases of the nervous system, genetic diseases, endocrine diseases, lung diseases, serious or uncontrolled cardiovascular diseases, clinically significant kidney or liver diseases, diseases of the blood system, any other clinically significant disease, and others that the investigators consider would increase the risk of disease of the subject.
- Pregnant or lactating women, who intend to become pregnant or who declare that they have intended to become pregnant within the previous 3 months.
- Consumption of nutritional supplements 4-6 weeks before screening.
- Consumption of probiotic or antibiotic products in the last two weeks.
- Women who have received chelation therapy for Pb poisoning.
- Known or suspected allergy or sensitivity to study products or any component tested in the trial.
- Participation in another clinical trial or food study 4 weeks before and during the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard <TM>/MegametalliQ <TM>) to Reduce Blood Lead Levels in Young Women of Child-bearing Age (18 to 40 Years Old)
We hypothesize that Lactobacillus Plantarum DSM 33464 reduce lead levels. Approximately 200 women 18 to 40 will be screened for blood lead levels. From that pool of subjects, 40 healthy women aged 18 to 40 years will participate in this randomized, placebo controlled pilot clinical trial. Each participant will receive 1 sachet of Lactobacillus Plantarum DSM 33464 (2g) per day for 8 weeks. The participants will be evaluated for several health measures, e.g. Blood, urine and hair will be collected and analyzed for lead (Pb) as the primary target compound and other chemicals as secondary target compounds. Adverse events will be recorded throughout the trial. Stool samples will also be collected at the beginning and end of the study to undertake a microbiome analysis.
Read the detailed description
Introduction: Lead (Pb) is a heavy metal, toxic to humans. Exposure to Pb has been associated with a wide range of adverse health effects and is one of the major environmental health problems in terms of the number of people exposed and the cost of the public health implications involved. However, a major limitation in the treatment of chronic Pb exposure is that there is no successful treatment to decrease absorption and increase excretion via the gastrointestinal tract, particularly when exposure occurs at medium and low levels where most of the population is concentrated.
Objective: To explore the efficacy of Lactobacillus plantarum DSM 33464 (SmartGuardTM/MegametalliQTM) in reducing blood lead (PbS) levels in women over an 8-week period.
Methods: Double-blind, randomized, placebo-controlled clinical trial. The study consists of two stages: screening and supplementation. In the first stage of the study, a participant selection process will be carried out for which 200 women between 18 and 40 years of age, residents of Colonia Santa Fe, Mexico City, will be invited to undergo screening procedures to identify those who meet the inclusion criteria of the study. From this group, 40 women will be selected to continue participating in the second stage of the clinical trial. Through randomization, the participants will be assigned to the control group (placebo) or treatment (SmartGuardTM/MegametalliQTM). The supplementation will last 8 weeks (2 months), each participant will be given a kit including a box with 40 sachets, the participant will receive one box at visit 1 and a second box at visit 2 (1 sachet per day, each sachet containing 2 g. of SmartGuardTM/MegametalliQTM or placebo). A total of 80 sachets will be given so that the participant will have extra sachets in case she does not attend the second visit at exactly 4 weeks, or if she misplaces them for any reason; however, it will be emphasized that only 1 sachet per day should be taken and the leftovers should be returned to the researcher in charge for their correct disposal and elimination. During the intervention period, 4 visits are planned (V1, V2, V3 and V4) in which blood, urine and hair samples will be collected and analyzed and used to quantify the levels of Pb (main objective) and other chemical substances (secondary objective). At visits V1 and V3, stool samples will be collected for microbiome analysis. Participants will then be monitored for a further 4 weeks to assess medium-term effectiveness, as well as to identify any subsequent complications, such as micronutrient depletion.
- Conditions
- Elevated Blood Lead Levels
- Being tested
- Lactobacillus plantarum DSM 33464, MegaMetalliQ, Placebo
- Keywords
- Blood lead level, Lactobacillus Plantarum DSM 33464
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum DSM 33464, MegaMetalliQDietary supplement
Pour Lactobacillus Plantarum DSM 33464 sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.
PlaceboDietary supplement
Pour placebo sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum DSM 33464, MegaMetalliQ | Experimental | Subjects will take 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) per day for 8 weeks Receives: Dietary Supplement: Lactobacillus plantarum DSM 33464, MegaMetalliQ |
| placebo group | Placebo comparator | Subjects will take 1 sachet of Placebo (2 g) per day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lead levels
Evaluate the effect of L. plantarum DSM 33464 to reduce the levels of blood lead in women during a period of 8 weeks in comparison with the ingestion of placebo.
Measured: 8 weeks
Secondary outcomes (7)
Blood lead levels
Evaluate the change in blood lead levels in response to ingestion of DSM 33464 (MegaMetalliQ<TM>)in participating women during the supplementation period compared to women in the placebo group.
Measured: 4 weeks
Hair lead levels
Evaluate the change in hair lead levels in response to ingestion of DSM 33464 in participating women during the supplementation period compared to women in the placebo group.
Measured: 4 and 8 weeks
Profile of heavy metal elements in the hair
The elements to be measured are Mg, P, S, Ca, Cr, Cu, Zn, Sr, Sn, I, Ba, Li, Al, Mn, Fe, Co, Ni, As, Cd, Hg, Bi, with the same unit g/dL
Measured: 4 and 8 weeks
Composition of fecal microbiota
The composition of fecal microbiota will be measured in response to ingestion of DSM 33464 compared to ingestion of placebo.
Measured: 8 weeks
Profile of heavy metal elements in the blood
The elements to be measured are Ca, Fe, Zn, Mg, Co, with the same unit g/dL
Measured: 4 and 8 weeks
Profile of heavy metal elements in the urine
The elements to be measured are summarized in the protocol, examples are Bisphenol A and Butyl Paraben with the same measurement unit
Measured: 4 and 8 weeks
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Measured: 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 Aug 2022
- Study start31 Oct 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Iberoamericana A.C., Mexico, Linus Biotechnology Inc
- Responsible party
- Sponsor
- Investigators
- Alejandra de Jesús Cantoral Preciado, Ph.D, Principal investigator, Universidad Iberoamericana A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507021
- Sponsor's protocol ID
- NZ-2021-03
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2022
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. 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 <TM>/MegametalliQ <TM>) to Reduce Blood Lead Levels in Young Women of Child-bearing Age (18 to 40 Years Old)
- ClinicalTrials.gov ID
- NCT05507021
- Acronym / sponsor ID
- NZ-2021-03
- Conditions
- Elevated Blood Lead Levels
- Keywords
- Blood lead level, Lactobacillus Plantarum DSM 33464
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Iberoamericana A.C., Mexico, Linus Biotechnology Inc
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 18 Aug 2022 (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.
We hypothesize that Lactobacillus Plantarum DSM 33464 reduce lead levels. Approximately 200 women 18 to 40 will be screened for blood lead levels. From that pool of subjects, 40 healthy women aged 18 to 40 years will participate in this randomized, placebo controlled pilot clinical trial. Each participant will receive 1 sachet of Lactobacillus Plantarum DSM 33464 (2g) per day for 8 weeks. The participants will be evaluated for several health measures, e.g. Blood, urine and hair will be collected and analyzed for lead (Pb) as the primary target compound and other chemicals as secondary target compounds. Adverse events will be recorded throughout the trial. Stool samples will also be collected at the beginning and end of the study to undertake a microbiome analysis.
Detailed description
Introduction: Lead (Pb) is a heavy metal, toxic to humans. Exposure to Pb has been associated with a wide range of adverse health effects and is one of the major environmental health problems in terms of the number of people exposed and the cost of the public health implications involved. However, a major limitation in the treatment of chronic Pb exposure is that there is no successful treatment to decrease absorption and increase excretion via the gastrointestinal tract, particularly when exposure occurs at medium and low levels where most of the population is concentrated.
Objective: To explore the efficacy of Lactobacillus plantarum DSM 33464 (SmartGuardTM/MegametalliQTM) in reducing blood lead (PbS) levels in women over an 8-week period.
Methods: Double-blind, randomized, placebo-controlled clinical trial. The study consists of two stages: screening and supplementation. In the first stage of the study, a participant selection process will be carried out for which 200 women between 18 and 40 years of age, residents of Colonia Santa Fe, Mexico City, will be invited to undergo screening procedures to identify those who meet the inclusion criteria of the study. From this group, 40 women will be selected to continue participating in the second stage of the clinical trial. Through randomization, the participants will be assigned to the control group (placebo) or treatment (SmartGuardTM/MegametalliQTM). The supplementation will last 8 weeks (2 months), each participant will be given a kit including a box with 40 sachets, the participant will receive one box at visit 1 and a second box at visit 2 (1 sachet per day, each sachet containing 2 g. of SmartGuardTM/MegametalliQTM or placebo). A total of 80 sachets will be given so that the participant will have extra sachets in case she does not attend the second visit at exactly 4 weeks, or if she misplaces them for any reason; however, it will be emphasized that only 1 sachet per day should be taken and the leftovers should be returned to the researcher in charge for their correct disposal and elimination. During the intervention period, 4 visits are planned (V1, V2, V3 and V4) in which blood, urine and hair samples will be collected and analyzed and used to quantify the levels of Pb (main objective) and other chemical substances (secondary objective). At visits V1 and V3, stool samples will be collected for microbiome analysis. Participants will then be monitored for a further 4 weeks to assess medium-term effectiveness, as well as to identify any subsequent complications, such as micronutrient depletion.
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, MegaMetalliQ | Experimental | Dietary Supplement: Lactobacillus plantarum DSM 33464, MegaMetalliQSubjects will take 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) per day for 8 weeks |
| placebo group | Placebo comparator | Dietary Supplement: PlaceboSubjects will take 1 sachet of Placebo (2 g) per day for 8 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between 18 and 40 years old.
- Women with capillary blood Pb levels between 3.3 µg/dL (Lead Care detection limit) and 25 µg/dL.
- Residents of Santa Fe, Mexico City.
- Women of childbearing age, using the same contraceptive method (any) since at least 3 cycles before the start of the study and who agree to maintain it for the entire duration of the study.
- Women who give their informed consent in writing.
Key exclusion criteria (7 listed)
- Women with a diagnosed history of diseases of the nervous system, genetic diseases, endocrine diseases, lung diseases, serious or uncontrolled cardiovascular diseases, clinically significant kidney or liver diseases, diseases of the blood system, any other clinically significant disease, and others that the investigators consider would increase the risk of disease of the subject.
- Pregnant or lactating women, who intend to become pregnant or who declare that they have intended to become pregnant within the previous 3 months.
- Consumption of nutritional supplements 4-6 weeks before screening.
- Consumption of probiotic or antibiotic products in the last two weeks.
- Women who have received chelation therapy for Pb poisoning.
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 33464, MegaMetalliQPour Lactobacillus Plantarum DSM 33464 sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time. | Dietary supplement | Lactobacillus plantarum DSM 33464, MegaMetalliQ |
| PlaceboPour placebo sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time. | Dietary supplement | placebo group |
Primary outcome
Blood Lead levels
Time frame: 8 weeks
Evaluate the effect of L. plantarum DSM 33464 to reduce the levels of blood lead in women during a period of 8 weeks in comparison with the ingestion of placebo.
7 secondary outcomes
Blood lead levels
Time frame: 4 weeks
Hair lead levels
Time frame: 4 and 8 weeks
Profile of heavy metal elements in the hair
Time frame: 4 and 8 weeks
Composition of fecal microbiota
Time frame: 8 weeks
Profile of heavy metal elements in the blood
Time frame: 4 and 8 weeks
Profile of heavy metal elements in the urine
Time frame: 4 and 8 weeks
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Time frame: 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 23 Sep 2024.
- 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.
Alejandra de Jesús Cantoral Preciado, Ph.D principal investigator
Universidad Iberoamericana A.C.
1 site 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, MegaMetalliQ in people with Elevated Blood Lead Levels, run by Novozymes A/S at 1 site in Mexico.
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 7 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Blood Lead levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.