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

NCT06026228 | Not Yet Recruiting DMC

• 2 other identifiers: 21_RIPH3-082021-A02293-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chlordecone (Kepone) Toxicity

Keywords

Chlordecone toxicity; Probiotics; Gut elimination; entero-hepatic cycle; plasma level concentration

Outcome Measures

Primary Outcomes (1)

• Chlordeconemia

  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.

  6 months

Secondary Outcomes (6)

• Chlordeconemia

  3 months

• Variation of chlordeconemia

  6 months

• concentration of CLD in the stool

  6 months

• Variation of chlordecone concentration in stool

  6 months

• Plasma total cholesterol concentrations

  6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: Placebo

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Limosilactobacillus reuteri

Interventions

Limosilactobacillus reuteri DIETARY_SUPPLEMENT

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

Also known as: BioGaïa® Gastrus

Experimental group

Placebo OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• Seen in clinical toxicology consultation at the CHU of Martinique during the study period
• Affiliated to a social security scheme
• Having received informed information on research
• Having freely given written and informed consent to participate in the research

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• BioGaia AB: collaborator
• University Hospital, Limoges: collaborator
• Regional Health Agency, Martinique: collaborator
• Biological Resource Centre, Martinique: collaborator
• Reims University hospital: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Martinique - Hôpital Pierre ZOBDA QUITMAN

Fort-de-France, France, 97261, Martinique

Location

Study Officials

• DABOR RESIERE, Professor

  University Hospital of Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEBASTIEN CAVALINI

CONTACT

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

CORINE CARPIN

CONTACT

+596 596 592 696; corine.carpin@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be carried out by the hospital pharmacy, which will dispense the appropriate batches to the team, following the randomisation list established by the Methodology and Data Management Centre. The hospital pharmacy, will keep a batch matching table, which will be made available to the vigilance unit and the Methodology and Data Management Centre. Masking will be maintained throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a study in two parallel groups of equal numbers: control group (placebo) and experimental group (probiotic). The control group will receive daily a placebo capsule per os at mealtime (just before or after) for a period of 6 months. The experimental group will receive daily per os one capsule of BioGaia® Gastrus probiotic , taken at mealtime (just before or after) for a period of 6 months.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)