The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Probiotics on Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
Probiotics could attenuate renal function deterioration in CKD patients.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Probiotics Renal Function Other: Probioics Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Probiotics on Chronic Kidney Disease
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : August 19, 2021
Actual Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Probiotics
Taking two capsules of probiotics twice daily for 12 months.
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.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228563


Locations
Layout table for location information
Taiwan
China Medical University Hospital
Taichung, Taiwan, 413
Sponsors and Collaborators
China Medical University Hospital
Investigators
Layout table for investigator information
Study Director: I-kuan Wang China Medical University Hospital
Layout table for additonal information
Responsible Party: I-Kuan Wang, Attending physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03228563    
Other Study ID Numbers: CMUH106-REC1-015
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes