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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Chlordeconemia
研究概览
简要总结
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.
详细描述
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reuteri ATCC PTA 6475 (BioGaia® Gastrus) is currently the best possible formulation for optimal hydrolase activity (unpublished data from BioGaia® laboratory).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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control group
The control group will receive daily a placebo capsule per os at mealtime (just before or after) for a period of 6 months
干预措施: Placebo (Other)
Experimental group
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
干预措施: Limosilactobacillus reuteri (Dietary Supplement)
结局指标
主要结局
Chlordeconemia
时间窗: 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.
次要结局
- Chlordeconemia(3 months)
- Variation of chlordeconemia(6 months)
- concentration of CLD in the stool(6 months)
- Plasma total cholesterol concentrations(6 months)
- Variation of chlordecone concentration in stool(6 months)
- Clinical tolerance to BioGaia® Gastrus probiotic or placebo(6 months)