Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Env… (NCT06026228) | Clinical Trial Compass
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 range18 Years
SexALL
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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 \> 1ÎĽg/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)
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