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The Effect of Probiotics on Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03228563
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
I-Kuan Wang, China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE July 21, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date July 21, 2022
Actual Study Start Date  ICMJE May 23, 2017
Actual Primary Completion Date August 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
eGFR decline rate. [ Time Frame: 12 months. ]
Compare estimated glomerular filtration rate decline rate within baseline, 3, 6, 9 and 12 months after taking probiotics.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
eGFR decline rate [ Time Frame: three months ]
Compare estimated glomerular filtration rate decline rate within 3 months before and after taking probiotics.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
  • Change rate in serum pro-inflammatory cytokines (TNF-α, IL6 and IL18) and endotoxin. [ Time Frame: 12 months ]
    Compare TNF-α, IL6, IL18 and endotoxin concentration within baseline, 3, 6, 9 and 12 months after taking probiotics.
  • Average scores of gastrointestinal symptoms by questionnaire. [ Time Frame: 12 months. ]
    Gastrointestinal symptoms are evaluated by a study nurse using questionnaire at baseline, 3, 6, 9 and 12 months after intervention. The questionnaire included the stool form [1 = very hard (small hard lumps), 2 = hard stool (hard sausage shape), 3 = normal stool (sausage to banana shape), 4 = soft stool, 5 = muddy stool, 6 = watery stool], ease of defecation (1 = difficult, 2 = easy, 3 = very easy) and abdominal symptoms [frequency of upper abdominal pain, lower abdominal pain, borborygmus, and flatulence (1 = frequent, 2 = occasional, 3 = almost never)]. The average scores before and after the intervention were analyzed.
  • Relative abundance of intestinal microbiota. [ Time Frame: 12 months. ]
    Stools from the participants were collected before and after 3, 6, 9 and 12-month probiotics treatments for NGS assay. The abundance of Bifidobacterium and Lactobacillus in stool microbiotia will be assessed.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Probiotics on Chronic Kidney Disease
Official Title  ICMJE The Effect of Probiotics on Chronic Kidney Disease
Brief Summary Probiotics could attenuate renal function deterioration in CKD patients.
Detailed Description

Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected individuals. Chronic inflammation, which is widely seen in CKD including long-term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk. Inflammatory markers such as C-reactive protein, IL-6, IL-18, and TNF-α, are elevated in dialysis patients and can predict cardiovascular event and all-cause mortality. Endotoxin is bacterial lipopolysaccharide, and makes up the outer membrane of Gram-negative bacteria. Endotoxin is also an important source and also a marker of inflammation in CKD.

The natural intestinal microbiota is altered in CKD patients as an increase in aerobic bacteria such as E. coli and a decrease in anaerobic bacteria such as Bifidobacterium. Dysbiosis might contribute to the chronic inflammatory state in dialysis patients through endotoxemia, induction of the pro-inflammatory cytokine, and production of uremic toxins through fermentation of protein in the large intestine. Probiotics containing Bifidobacterium species and Lactobacilli species could benefit the host by inhibiting the growth or epithelial invasion of pathogenic bacteria, enhancing the intestinal barrier function, and regulating the immune system.

Probiotics could suppress proinflammatory cytokines, such as TNF-α and IL-6 . In addition, probiotics could improve renal function parameters in uremic rats and significantly lower levels of blood urea nitrogen in stage 3 and 4 CKD patients. The aim of the present study is to evaluate:

  1. Whether probiotics could retard the decline of renal function?
  2. Whether probiotics could change microbiota?
  3. Whether probiotics could reduce the serum levels of endotoxin and cytokines (TNF-α, IL-6, and IL-18)?
  4. Whether probiotics could improve the gastrointestinal symptoms in CKD patients?

Estimated glomerular filtration rate, stool microbiota, serum cytokines and endotoxin, and gastrointestinal symptoms of stage 3-5 patients are measured before and after intervention. The Wilcoxon signed-rank and Wilcoxon rank-sum tests were used to compare intra- and intergroup differences for continuous variables, as appropriate. A p value less than 0.05 was considered significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Probiotics
  • Renal Function
Intervention  ICMJE Other: Probioics
CKD Patients were supplemented with two capsules of probiotics containing 2.5*10^9 CFU Lactobacillus acidophilus (TYCA06), Bifidobacterium longum (BLI-02) and Bifidobacterium bifidum (VDD088) twice daily for 12 months.
Study Arms  ICMJE
  • Experimental: Probiotics
    Taking two capsules of probiotics twice daily for 12 months.
    Intervention: Other: Probioics
  • No Intervention: Healthy control
    Healthy volunteers were: no hypertension (Blood pressure<140/90mmHg), no diabetes (Glucose AC 70~100mg/dl), no hyperlipidemia (Cholesterol Total 130~200mg/dL、Triglyceride<150mg/dL), no urinary protein (-) and normal renal function (eGFR>90), after signing the consent form, the stool samples will be collected.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2022)
148
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2017)
40
Actual Study Completion Date  ICMJE April 30, 2022
Actual Primary Completion Date August 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Healthy volunteers:

The criteria for healthy volunteers were: no hypertension (Blood pressure<140/90mmHg), no diabetes (Glucose AC 70~100mg/dl), no hyperlipidemia (Cholesterol Total 130~200mg/dL、Triglyceride<150mg/dL), no urinary protein (-) and normal renal function (eGFR>90), after signing the consent form, the stool samples will be collected.

CKD patients:

Inclusion Criteria:

‧Stage 3-5 CKD patients, at least 20 years of age and regular follow-up for at least 6 months prior to enrollment.

Exclusion Criteria:

  • Pregnancy.
  • On immunosuppressive therapy.
  • Active infectious condition.
  • Acute kidney injury.
  • Consuming other forms of probiotics.
  • Taking antibiotics within 30 days prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03228563
Other Study ID Numbers  ICMJE CMUH106-REC1-015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party I-Kuan Wang, China Medical University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE China Medical University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: I-kuan Wang China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP