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A double-blind randomized controlled trial investigating the impact of probiotics on human plastic excretion

A double-blind randomized controlled trial investigating the impact of probiotics on human plastic excretion.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078354
Enrollment
Unknown
Registered
2023-12-06
Start date
2023-12-04
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Human body plastic discharge

Interventions

Intervention group:The intervention group received 1 package of blue-crystal microbial probiotics provided daily for 2 months for 60 days.
Control group:The control group received 1 packet of placebo daily for 2 months for 60 days.

Sponsors

Gansu Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Volunteers whose eating habits meet the relatively high exposure standard of microplastics through the preliminary questionnaire survey; (2) Volunteers who are healthy and have no history of acute disease or major chronic disease; (3) Volunteers who are not currently participating in other relevant experimental projects; (4) Volunteers who have not developed any acute gastrointestinal disease in the past three months and have no history of chronic gastrointestinal disease; (5) Age 18-45 years old, gender is not limited; (6) Volunteers who voluntarily participate in this project and have a high degree of cooperation.

Exclusion criteria

Exclusion criteria: (1) Those who are unwilling to cooperate with the project; (2) Volunteers whose eating habits did not meet the high microplastic exposure standard through the preliminary questionnaire survey; (3) Suffering from serious systemic diseases and infections, malignant diseases such as tumors, serious heart, liver, kidney diseases, acute gastrointestinal diseases, fever and other diseases that have an impact on intestinal flora; (4) Volunteers who had taken antibiotics within three months; (5) People who take various health care products for various reasons within a week; The use of other physiotherapy instruments or any topical drugs or health products within a week to promote digestive function and affect intestinal flora will affect the subjects in this study.

Design outcomes

Primary

MeasureTime frame
Six items of male sex hormones((Testosterone,T),(Estradiol,E2),(Progesterone,P),(Luteinizing hormone,LH),(Follicle-stimulating hormone,FSH),(prolactin,PRL));Microplastics detection;

Secondary

MeasureTime frame
Blood routine examination(RBC,WBC,Hb,NEUT,LYM,PLT,MO);urinalysis(PH,SG,GLU,PRO,RBC,WBC,KET);Stool routine examination(WBC,RBC,OB);Blood biochemistry complete(ALT,AST,LDH,CK,ALP,GGT,GLU,TBil,DBil,TC,TG,TP,ALB,BUN,UA,Cr,K+,Na+,Cl-,Ca2+);

Countries

China

Contacts

Public ContactXudong Lei

Gansu Provincial Cancer Hospital

leixudong0919@163.com+86 180 8938 5839

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026