Chlordecone (Kepone) ToxicityCHLOR-DETOXNCT06026228
Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Environmentally Exposed to Pesticide in Martinique.
A study testing Limosilactobacillus reuteri in people with Chlordecone (Kepone) Toxicity, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chlordecone (Kepone) Toxicity
- What is being tested?
- Limosilactobacillus reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMartinique
- Study dates
- Apr 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
Martinique1 site
Centre Hospitalier Universitaire de Martinique - Hôpital Pierre ZOBDA QUITMAN
Fort-de-France, France, 97261
SEBASTIEN CAVALINI, +596 596 592 696, sebastien.cavalini@chu-martinique.fr
CORINE CARPIN, +596 596 592 696, corine.carpin@chu-martinique.fr
About this study
Official title: Effects of Oral Intake of the Probiotic Limosilactobacillus Reuteri on Plasma Chlordecone (Kepone) Concentrations (Chlordeconemia) in Individuals Environmentally Exposed to the Organochlorine Pesticide in Martinique : an Exploratory Pilot Study
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.
Read the 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 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.
- Conditions
- Chlordecone (Kepone) Toxicity
- Being tested
- Limosilactobacillus reuteri, Placebo
- Keywords
- Chlordecone toxicity, Probiotics, Gut elimination, entero-hepatic cycle, plasma level concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limosilactobacillus reuteriDietary supplement
Also called BioGaïa® Gastrus
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
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Limosilactobacillus reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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 T3months will be compared between the BioGaia® Gastrus probiotic treated group and the placebo treated group.
This relative variation will be calculated as the ratio of the difference in chlordeconemia T0 -T3months to the initial chlordeconemia at T0.
Measured: 3 months
Variation of chlordeconemia
The relative variation of chlordeconemia from T0 to T6 months in each group of patients (probiotic group, placebo group) will be described. The plasma half-life values of CLD, expressed in months, will be determined for each group.
Measured: 6 months
concentration of CLD in the stool
The concentration of CLD in the stool at 3 months (T3 months) and 6 months (T6 months) will be measured using the same method described in the primary outcome (GC/MS technique). The relative changes in stool CLD concentration between T0 and T3mois and T0 and T6mois will be compared between the BioGaia® Gastrus probiotic treated group and the placebo treated group.
Measured: 6 months
Variation of chlordecone concentration in stool
- The relative change in stool CLD concentration from T0 to T6months within each patient group (probiotic group, placebo group) will be described
Measured: 6 months
Plasma total cholesterol concentrations
Plasma total cholesterol concentrations, measured by the reference technique (ultracentrifugation followed by heparin-manganese precipitation and then quantification by the Abell-Kendall method) at T0 , T3 months and T6 months will be described. The relative variations of plasma total cholesterol concentrations between T0 and T3months and T0 and T6months will be compared between the group of patients treated with the BioGaia® Gastrus probiotic and the group of patients treated with placebo.
Measured: 6 months
Clinical tolerance to BioGaia® Gastrus probiotic or placebo
Treatments will be assessed by adverse event reporting and based on a standardised and internationally recognised toxicity table for adults.
This tolerance will be assessed by a telephone interview at T1 month, T2 months, T4 months and T5 months, as well as during face-to-face follow-up visits at T3months and T6months .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlordecone (Kepone) ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB, University Hospital, Limoges, Regional Health Agency, Martinique, Biological Resource Centre, Martinique, Reims University hospital
- Responsible party
- Sponsor
- Investigators
- DABOR RESIERE, Professor, Principal investigator, University Hospital of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026228
- Sponsor's protocol ID
- 21_RIPH3-08
- Other IDs
- 2021-A02293-38
- Acronym
- CHLOR-DETOX
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Intake of the Probiotic Limosilactobacillus Reuteri on Plasma Chlordecone (Kepone) Concentrations (Chlordeconemia) in Individuals Environmentally Exposed to the Organochlorine Pesticide in Martinique : an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06026228
- Acronym / sponsor ID
- CHLOR-DETOX / 21_RIPH3-08
- Conditions
- Chlordecone (Kepone) Toxicity
- Keywords
- Chlordecone toxicity, Probiotics, Gut elimination, entero-hepatic cycle, plasma level concentration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- BioGaia AB, University Hospital, Limoges, Regional Health Agency, Martinique, Biological Resource Centre, Martinique, Reims University hospital
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: PlaceboThe control group will receive daily a placebo capsule per os at mealtime (just before or after) for a period of 6 months |
| Experimental group | Experimental | Dietary Supplement: Limosilactobacillus reuteriThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limosilactobacillus reuteriAlso: BioGaïa® GastrusThe 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 | Dietary supplement | Experimental group |
| PlaceboThe 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. | Other | Control group |
Primary outcome
Chlordeconemia
Time frame: 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.
6 secondary outcomes
Chlordeconemia
Time frame: 3 months
Variation of chlordeconemia
Time frame: 6 months
concentration of CLD in the stool
Time frame: 6 months
Variation of chlordecone concentration in stool
Time frame: 6 months
Plasma total cholesterol concentrations
Time frame: 6 months
Clinical tolerance to BioGaia® Gastrus probiotic or placebo
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DABOR RESIERE, Professor principal investigator
University Hospital of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri in people with Chlordecone (Kepone) Toxicity, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEBASTIEN CAVALINI (+596 596 592 696, sebastien.cavalini@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chlordeconemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.