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Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Environmentally Exposed to Pesticide in Martinique.

NCT06026228 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-21

No results posted yet for this study

Summary

The CHLOR-DETOX study is a single-centre, double-blind, prospective, interventional, controlled, exploratory pilot study on subjects environmentally exposed to the organochlorine pesticide (kepone or chlordecone, CLD) in the French Caribbean (Martinique island). To our best knowledge, it is the first clinical trial in such subjects evaluating the potential effect of oral probiotic intake (Limosilactobacillus reuteri) on the reduction of CLD plasma levels (chlordeconemia) and fecal excretion, thus concurring to the reduction of CLD toxicity in study subjects.

Conditions

  • Chlordecone (Kepone) Toxicity

Interventions

DIETARY_SUPPLEMENT

Limosilactobacillus reuteri

The BioGaia® Gastrus probiotic capsule contains the following components: L. reuteri DSM 17938, L. reuteri ATCC PTA 6475) at 10\^8 CFU\*/day, fully hydrogenated palm oil; ascorbic acid; tangerine flavour and mint flavour. \*Colony forming Unit

OTHER

Placebo

The placebo capsules have the same external appearance and composition as the BioGaia® Gastrus Limosilactobacillus reuteri probiotic capsule (combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475), but without the active ingredient.

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • University Hospital, Limoges

    collaborator OTHER

  • Regional Health Agency, Martinique

    collaborator UNKNOWN

  • Biological Resource Centre, Martinique

    collaborator UNKNOWN

  • Reims University hospital

    collaborator OTHER

  • University Hospital Center of Martinique

    lead OTHER

Principal Investigators

  • DABOR RESIERE, Professor · University Hospital of Martinique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-04-30
Completion
2026-10-31

Countries

  • Martinique

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 NCT06026228 on ClinicalTrials.gov