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OpenTrials
Completed

NCT Number: NCT06984575

Relationship Between Intestinal Flora Changes and Hyperuricemia Under Chronic Psychological Stress

To clarify the mechanism of stress on the incidence of hyperuricemia

Completed

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Key information

Age range

18 year–69 year

Sex eligibility

Male

Study type

Observational

Primary location

Shanghai Tenth People's hospital

Shanghai, Shanghai Municipality, 200070, China

About this study

To clarify the differences in intestinal microorganisms and metabolism between healthy people and hyperuricemia patients and across different level of stress

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obtain the informed consent of the subjects before conducting any trial-related activities;
  • Males aged 18-69;
  • The hyperurcemia group must meet the diagnostic criteria of having blood uric acid >420umol/L measured twice on an empty stomach on different days under a normal purine diet;

Exclusion criteria

  • 1)Use of any uric acid-lowering drugs, anti-gout drugs, steroids, proton pump inhibitors, or non-steroidal anti-inflammatory drugs within one month before enrollment; 2)Use of any antibiotics, probiotics, or other drugs including traditional Chinese medicine within one month before enrollment; 3)Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; 4)Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.

5)Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2; 6)Secondary hyperuricemia 7)Any gastrointestinal diseases

Treatment and study plan

No interventions

Other

No interventions

Primary outcomes

  1. Phenotype differences in the gut microbiome by metagenomic sequencing.

    Time frame: Samples to be collected once per participant within 7 days of enrollment

    including microbial composition analysis(Taxonomic Annotation Tools: MetaPhlAn4; Functional Gene Analysis Tools:eggNOG-mapper (functional classification) and diversity metrics(α-diversity (Shannon index) and β-diversity (Bray-Curtis distance, UniFrac distance)

  2. sequencing results of the fecal metabolome in the population

    Time frame: Samples to be collected once per participant within 7 days of enrollment

Secondary outcomes

  1. Serum uric acid

    Time frame: Samples to be collected once per participant within 7 days of enrollment

    Uric acid in umol/L.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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