Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05507021 |
| Other study ID # |
NZ-2021-03 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2022 |
| Est. completion date |
April 13, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Novozymes A/S |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
