Status:
NOT_YET_RECRUITING
Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Environmentally Exposed to Pesticide in Martinique.
Lead Sponsor:
University Hospital Center of Martinique
Collaborating Sponsors:
BioGaia AB
University Hospital, Limoges
Conditions:
Chlordecone (Kepone) Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
The research question focuses on the ability of the probiotic Limosilactobacillus reuteri Gastrus (combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 from the BioGaia® company) to reduce...
Eligibility Criteria
Inclusion
- 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
- 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)
- Persons deprived of their liberty by a judicial or administrative decision,
- Persons staying in a health or social care institution for purposes other than research
- Persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06026228
Start Date
April 1 2024
End Date
October 1 2026
Last Update
February 21 2024
Active Locations (1)
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1
Centre Hospitalier Universitaire de Martinique - Hôpital Pierre ZOBDA QUITMAN
Fort-de-France, France, Martinique, 97261