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Completed

NCT Number: NCT03010735

Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)

The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.

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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

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Anzhen Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18 years old
  • Patients who diagnosed as ESRD with hemodialysis
  • Fixed hemodialysis cycle (average 3 times a week)
  • Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
  • Agree to sign the informed consent form

Exclusion criteria

  • Taking antibiotics or antifungal drugs within 30 days before the study
  • Have serious allergic reaction to skim milk powder
  • Researcher 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

Probiotics

Dietary Supplement

Daily take 4.0E+10 CFU of probiotics

Placebo

Dietary Supplement

Primary outcomes

  1. Changes in Microbiota-derived uremic toxin

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

Secondary outcomes

  1. Changes in Fecal Microbiome

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  2. Changes in Fecal metabolites

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  3. Changes in Blood metabolites

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  4. Defecation questionnaire

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  5. Gastrointestinal Symptoms

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  6. The Kidney Disease Quality of Life

    Time frame: 6 months

    follow up the patients at Month 0, 3, 6

  7. The Occurrence of Cardiovascular Event

    Time frame: 6 month follow-up

Sponsors and collaborators

Lead sponsor

China Agricultural University

Other

Collaborators

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

Registry information

Official study title

Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)

Important dates

Study start
2015
Primary completion
2017
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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