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
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
* 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.
Primary outcome measure(s)
Chlordeconemia — 6 months Chlordeconemia measured by a gas chromatography/mass spectrometry (GC/MS) technique expressed in μg/L (analytical detection limit LDD of 0.05 μg/L - quantification limit LDQ of 0.1 μg/L)
The relative change in chlordeconemia between T0 and T6 months will be compared between the group of patients treated with the BioGaia® Gastrus probiotic and the group of patients treated with placebo.
This relative variation will be calculated as the ratio of the difference in chlordeconemia T0 -T6mois to the initial chlordeconemia at T0.
Trial sites (1)
Facility
City
Region
Status
Centre Hospitalier Universitaire de Martinique - Hôpital Pierre ZOBDA QUITMAN
Fort-de-France
France
More University Hospital Center of Martinique trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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