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Evaluation of the efficacy and safety of probiotics intervention in occupational heavy metal exposure: a randomized, controlled, multicenter clinical trial

Evaluation of the efficacy and safety of probiotics intervention in occupational heavy metal exposure: a randomized, controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123190
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive levels of heavy metals

Interventions

Life Intervention Group:Daily supplementation of minerals and vitamins, along with lifestyle interventions such as physical exercise, for a total treatment course of 4 weeks.
Probiotic Intervention plus Lifestyle Intervention Group:Probiotics (containing 10^9 CFU of live probiotics and prebiotics), 1 packet, twice daily (bid), combined with daily supplementation of mineral
Limosilactobacillus reuteri[Product Preservation No. and Batch No.: B80650=ATCC 23272
20241205])

Sponsors

West China Fourth Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years old, occupational exposure workers. 2. Occupational exposure history: Engaged in heavy metal mining or metallurgical-related industries, with lead exposure >=3 months, mercury exposure >=6 months, arsenic exposure >=3 months, cadmium exposure >=1 year, and no withdrawal from the exposure environment within the past 3 months. 3. Occupational populations exceeding the aforementioned standards but not meeting the diagnostic criteria for occupational poisoning, in accordance with guidelines and standards such as the WHO Clinical Management Guidelines for Lead Exposure, Biological Limit Values for Occupational Exposure to Mercury (WST 265-2006), Safe Guideline Levels for Arsenic in Human Urine (WST 665-2019), and the EU Occupational Biological Limit Values (Directive (EU) 2019/983). 4. Heavy metal standards for human biological samples: Blood lead level >=50 µg/L; Urinary mercury >=20 µmol/mol creatinine (>=35 µg/g creatinine); Urinary arsenic >=32 µg/L Urinary cadmium >=2 µg/g creatinine;

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Concomitant severe diseases: hepatic or renal insufficiency (ALT>80 U/L or Cr>133 µmol/L), malignant tumors, and autoimmune diseases. 3. Recent intervention history: Use of antibiotics, probiotics, or heavy metal chelators within 4 weeks prior to intervention. 4. Allergy history: Allergy to dairy products or probiotic components. 5. High risk of lost to follow-up: Inability to ensure follow-up compliance (e.g., frequent business trips, remote residence locations).

Design outcomes

Primary

MeasureTime frame
Blood and urine heavy metal load;Alpha/beta diversity index of gut microbiota;

Secondary

MeasureTime frame
Clinical Symptoms and Signs ;Inflammatory markers: IL-6, CRP;Metabolic indicators: blood glucose, insulin levels;

Countries

China

Contacts

Public ContactDu Yu

West China Fourth Hospital, Sichuan University

456duyu@163.com+86 133 4897 2113

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026