NCT05507021

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

August 9, 2022

Last Update Submit

September 19, 2024

Conditions

Elevated Blood Lead Levels

Keywords

Blood lead levelLactobacillus Plantarum DSM 33464

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (7)

  • Blood lead levels

    4 weeks

  • Hair lead levels

    4 and 8 weeks

  • Profile of heavy metal elements in the hair

    4 and 8 weeks

  • Composition of fecal microbiota

    8 weeks

  • Profile of heavy metal elements in the blood

    4 and 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Lactobacillus plantarum DSM 33464, MegaMetalliQ

EXPERIMENTAL

Subjects will take 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) per day for 8 weeks

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

Dietary Supplement: Placebo

Interventions

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.

Lactobacillus plantarum DSM 33464, MegaMetalliQ
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.

placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details• Women between 18 and 40 years old.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Iberoamericana A.C.

Mexico City, 01219, Mexico

Location

Study Officials

  • Alejandra de Jesús Cantoral Preciado, Ph.D

    Universidad Iberoamericana A.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 18, 2022

Study Start

October 31, 2022

Primary Completion

April 12, 2023

Study Completion

April 12, 2023

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)