Not Yet RecruitingNot Applicable

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

Martinique100 participantsStarted 2024-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, 18 years of age or older * Seen in clinical toxicology consultation at the CHU of Martinique during the study period * With an initial chlordeconemia \> 1μg/L on a test less than 1 month old at the time of study inclusion * Affiliated to a social security scheme * Having received informed information on research * Having freely given written and informed consent to participate in the research Exclusion Criteria: * History of cancer * Recent infections less than 6 months old * Known digestive diseases: chronic diarrhoea, ulcerative colitis, Crohn's disease, pancreatitis * Digestive procedures less than 6 months old. * Intrahepatic cholestasis less than 6 months old * Extrahepatic cholestasis less than 6 months old * Use of cholestyramine or ursodeoxycholic acid in the previous 3 months * Consumption of food (non-ordinary yoghurt, etc.) or supplements (tablets, drops, capsules, etc.) containing L. reuteri or any other probiotic within the previous 2 weeks. * Antibiotics taken in the previous 4 weeks. * Immune deficiency secondary to a pathology (lymphoma, leukaemia) or medical treatment (immunosuppressant, corticoid, chemotherapy). * Women who are unable to obtain contraception during the trial * Persons referred to in articles L.1121-5, L.1121-7, L. 1121-8 of the Public Health Code: * Pregnant woman, parturient or breastfeeding mother * Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Chlordeconemia

Timeframe: 6 months

Trial details

NCT IDNCT06026228

SponsorUniversity Hospital Center of Martinique

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

SEBASTIEN CAVALINI

+596 596 592 696 sebastien.cavalini@chu-martinique.fr

View on ClinicalTrials.gov More Chlordecone (Kepone) Toxicity trials