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Completed

NCT Number: NCT03010696

The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)

The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: Yes

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

For Healthy Subjects

Inclusion criteria

  • Age over 18 years old
  • Liver and kidney function is normal
  • 18.5≤BMI≤29.9
  • Agree to sign the informed consent form

Exclusion criteria

  • Diagnosed as Metabolic syndrome
  • Diagnosed as Cirrhosis
  • Diagnosed as kidney disease
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Taking antibiotics or antifungal drugs within 30 days before the study

For ESRD patients

Inclusion criteria

  • Age over 18 years old
  • Patients who diagnosed as ESRD with hemodialysis
  • Fixed hemodialysis cycle (average 3 times a week)
  • Agree to sign the informed consent form

Exclusion criteria

  • Taking antibiotics or antifungal drugs within 30 days before the study
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Reasercher are not sure whether the subjects are willing or able to complete the study
  • Subject participated in other research projects within two months before the study

Treatment and study plan

No interventions, questionnaire, collect specimen

Other

Primary outcomes

  1. Microbiota-derived uremic toxin

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Fecal Microbiome

    Time frame: Through study completion, an average of 1 year

  2. Fecal metabolites

    Time frame: Through study completion, an average of 1 year

  3. Blood metabolites

    Time frame: Through study completion, an average of 1 year

  4. Complete blood count

    Time frame: Through study completion, an average of 1 year

  5. Blood biochemistry test

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

China Agricultural University

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Heyiyuan Biotech Co. Ltd.
  • General Hospital of Chinese Armed Police Forces
  • Peking University Aerospace Center Hospital
  • Peking University Shougang Hospital
  • Shenzhen Microbiota Technology Co. Ltd.

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 5, 2017
Registry last updated
Oct 22, 2020

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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