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Effect of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Young Women of Child-bearing Age

NCT05507021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Elevated Blood Lead Levels

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum DSM 33464, MegaMetalliQ

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.

DIETARY_SUPPLEMENT

Placebo

Pour placebo sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.

Sponsors & Collaborators

  • Universidad Iberoamericana A.C., Mexico

    collaborator OTHER

  • Linus Biotechnology Inc

    collaborator UNKNOWN

  • Novozymes A/S

    lead INDUSTRY

Principal Investigators

  • Alejandra de Jesús Cantoral Preciado, Ph.D · Universidad Iberoamericana A.C.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05507021 on ClinicalTrials.gov