An interventional study of Lactobacillus plantarum DSM 33464, MegaMetalliQ and Placebo in Elevated Blood Lead Levels, sponsored by Novozymes A/S. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Novozymes A/S · Not applicable, Interventional, and Supportive care
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.
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.
Novozymes A/S is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will take 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) per day for 8 weeks
Dietary Supplement: Lactobacillus plantarum DSM 33464, MegaMetalliQ
Subjects will take 1 sachet of Placebo (2 g) per day for 8 weeks
Dietary Supplement: Placebo
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.
Pour placebo sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 4 and 8 weeks
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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