Exploring the wet evidence biology of SHPT in hemodialysis patients based on gut flora whole genomics and metabolomics

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400090609

Enrollment

Unknown

Registered

2024-10-09

Start date

2024-01-05

Completion date

Unknown

Last updated

2024-10-15

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

Conditions

Secondary hyperparathyroidism in hemodialysis patients

Interventions

SHPT Group:None

Non-SHPT Group:None

Healthy control Group:None

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: I. Inclusion criteria for SHPT group: ? Age 18-70 years old; ?Maintenance hemodialysis for more than 3 months; ? Meet the diagnostic criteria of SHPT; ? Meet the diagnostic criteria of wet evidence; ? Laboratory tests within one month suggesting abnormalities in serum Ca, P, PTH or vitamin D, PTH>600pg/ml; ?Voluntarily participate in the clinical trial and sign the Information Leaflet for Informed Consent. II.Inclusion criteria of non-SHPT group: ? Age 18-70 years old; ?Maintenance hemodialysis for more than 3 months; ?Meet the diagnostic criteria of wet evidence; ?Voluntarily participate in the clinical trial and sign the Information Leaflet for Informed Consent.

Exclusion criteria

Exclusion criteria: I. Exclusion criteria for SHPT group: ?Patients with serious complications (liver, heart, lung, blood, metabolic and other diseases or malignant tumors); ?Taking probiotic preparations or antibiotic drugs within 4 weeks before enrollment; ?No acute inflammatory diseases such as acute gastroenteritis, influenza, etc. within 4 weeks before enrollment. ?Patients were judged by the investigator to have other unsuitable conditions for enrollment. II.Exclusion criteria for non-SHPT group: ?Patients with serious complications (liver, heart, lung, blood, metabolic and other diseases or malignant tumors); ?Patients who have taken probiotic preparations or antibiotic drugs within 4 weeks before enrollment; ?No acute inflammatory diseases such as acute gastroenteritis, influenza, etc. within 4 weeks before enrollment. ?Patients with other unsuitable conditions for enrollment as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Whole genome sequencing of intestinal flora;Metabolomics assays;	—

Secondary

Measure	Time frame
liver function;Myocardial enzyme;Blood electrolyte;Vitamin D;parathyroid hormone;Tongue Images;	—

Countries

China

Contacts

Public ContactMao Wei

Guangdong Provincial Hospital of Traditional Chinese Medicine

maowei@gzucm.edu.cn+86 138 0886 4963

Outcome results

None listed

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