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Evaluation of the efficacy and safety of probiotics, traditional Chinese medicine and chelating agent in the treatment of occupational heavy metal poisoning—Randomized, Controlled, Multicenter Clinical Trial

Evaluation of the efficacy and safety of probiotics, traditional Chinese medicine and chelating agent in the treatment of occupational heavy metal poisoning—Randomized, Controlled, Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123602
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

heavy metal poisoning

Interventions

Probiotic + Chelating Agent Treatment Group:Probiotic detoxification agent: 1 packet (containing probiotics and prebiotics), twice daily, oral
combined with conventional chelation therapy (CaNa2EDTA for lead poisoning, Na-DMPS for arsenic/mercury/cadmium poisoning), total of 2 courses, one course lasting 1 week (treatment + interval period).
Traditional Chinese Medicine Formula + Chelating Agent Treatment Group:First course: Traditional Chinese medicine formula treatment for 3-5 days, twice daily, oral, combined with conventional chelatio
add Atractylodes macrocephala 12g, Codonopsis pilosula 15g for obvious fatigue
add Eucommia ulmoides 10g, Achyranthes bidentata 10g for waist and knee soreness
add Rheum palmatum 10g, Mirabilis 4g, Magnolia officinalis 10g for constipation and abdominal pain
add Hawthorn 10g, Barley sprout 10g, Fermented wheat bran 10g for poor appetite).
Chelating Agent Treatment Group (Control Group):Conventional chelation therapy only, total of 2 courses, one course lasting 1 week (treatment + interval period). CaNa2EDTA for lead poisoning, Na-DMPS
Na-DMPS 2.5-5mg/kg per dose, dissolved in 5% glucose solution, intravenous drip, once daily, one course

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 exposure to lead >=3 months, mercury >=6 months, arsenic >=3 months, and cadmium >=1 year, and no withdrawal from the exposure environment within the past 3 months. 3. Patients who meet the criteria for chronic poisoning according to national occupational health standards such as the Diagnostic Criteria for Occupational Lead and Inorganic Compound Poisoning (GBZ 37-2024), Diagnostic Criteria for Occupational Mercury Poisoning (GBZ 89-2024), Diagnostic Criteria for Occupational Arsenic Poisoning (GBZ 83-2025), and Diagnostic Criteria for Occupational Cadmium Poisoning (GBZ 17-2015). 4. Heavy metal standards for human biological samples: 1) Blood lead level >=600 µg/L or urinary lead level >=120 µg/L; 2) Urinary mercury >=20 µmol/mol creatinine (>=35 µg/g creatinine); 3) Urinary arsenic >=32 µg/L 4) Urinary cadmium >=5 µmol/mol creatinine (5 µg/g creatinine); 5. Signing the informed consent form: Voluntary participation and signing of the ethical review documents.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Concurrent 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, probiotics, or traditional Chinese medicine 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 ;Traditional Chinese Medicine Syndrome Score ;Organ function: Complete blood count, liver and kidney function tests;Health-related Quality of Life Score;

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 7, 2026