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

University Hospital Center of Martinique

Status: Not yet enrolling

Conditions: Chlordecone (Kepone) Toxicity

Treatments: Other: Placebo; Dietary Supplement: Limosilactobacillus reuteri

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06026228

21_RIPH3-08

2021-A02293-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 CLD toxicity in subjects exposed to this pesticide. In particular, the investigators are interested in whether the oral prescription of Limosilactobacillus reuteri reduces plasma levels of CLD by increasing the fecal excretion of the deconjugated form of CLD. This research hypothesis is based on the presence of a hydrolase activity (glucuronidase) in Limosilactobacillus reuteri that allows the deconjugation of glucuronide derivatives (De Boever et al 2000; Cardona et al. 2002; Martoni et al 2008). Limosilactobacillus reuteri is the probiotic with the highest hydrolase activity. The combination of Limosilactobacillus reuteri DSM 17938 and Limosilactobacillus reuteri ATCC PTA 6475 (BioGaia® Gastrus) is currently the best possible formulation for optimal hydrolase activity (unpublished data from BioGaia® laboratory). The investigators also hypothesize that the increase in CLD elimination by the digestive tract through the use of Limosilactobacillus reuteri avoids the appearance of side effects encountered during the prolonged use of classical bile salt sequestrants (e.g. QUESTAN).

The effects of oral prescription of Limosilactobacillus reuteri on plasma levels and faecal concentrations of CLD will be compared with a control group under placebo.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

The control group will receive daily a placebo capsule per os at mealtime (just before or after) for a period of 6 months

Treatment:

Other: Placebo

Experimental group

Experimental group

Description:

The experimental group will receive daily per os one capsule of BioGaia® Gastrus probiotic (combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) dosed at 108 colony forming units (CFU)/day (distributed by the laboratory PEDIACT France), taken at mealtime (just before or after) for a period of 6 months

Treatment:

Dietary Supplement: Limosilactobacillus reuteri