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Effects of Synbiotics Supplementation on the Uremic Toxin Indoxyl Sulfate Level and Constipation in End-stage Renal Disease Patients Undergoing Hemodialysis

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ClinicalTrials.gov Identifier: NCT04527640
Recruitment Status : Unknown
Verified August 2020 by Dr. Aida Lydia, PhD, SpPD-KGH, Indonesia University.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Aida Lydia, PhD, SpPD-KGH, Indonesia University

Study Description
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Brief Summary:
This is a double-blind, placebo-controlled, randomized clinical trial conducted to evaluate the effects of synbiotics supplementation on the level of the uremic toxin indoxyl sulfate, symptoms of constipation, and constipation-related quality of life in end-stage renal disease patients undergoing hemodialysis.

Condition or disease Intervention/treatment Phase
Constipation End Stage Renal Disease on Dialysis Dietary Supplement: Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg Other: Placebo Not Applicable

Detailed Description:

One of the most common gastrointestinal symptoms in end-stage renal disease patients undergoing hemodialysis is constipation, which is one of the risk factors of microbiota dysbiosis. One effect of dysbiosis is the increased level of a uremic toxin known as indoxyl sulfate. The accumulated concentration of indoxyl sulfate in end-stage renal disease patients undergoing hemodialysis is associated with inflammation and oxidative stress, which in turn increases the risk of cardiovascular event. Constipation and an increased risk of cardiovascular event is associated with low quality of life in chronic kidney disease patients undergoing hemodialysis.

Synbiotics administrations had become one of the many ways to improve gut dysbiosis as it is expected to lower the level of indoxyl sulfate and improve the symptoms of constipation and constipation-related quality of life. Although studies had investigated the role of probiotics/prebiotics/synbiotics, the role of synbiotics in lowering the concentration of the uremic toxin indoxyl sulfate remains inconclusive. Therefore, this study is conducted to demonstrate the benefits of synbiotics administration in lowering the concentration of indoxyl sulfate in end-stage renal disease patients undergoing hemodialysis, This is the first study in Indonesia investigating the effects of synbiotics supplementation in end-stage renal disease patients undergoing hemodialysis.

This study is a double-blind, placebo-controlled, randomized clinical trial conducted on end-stage renal disease patients undergoing hemodialysis. Patients will be divided into two arms: synbiotics and placebo. The study will take place in the hemodialysis unit of Dr. Cipto Mangunkusumo General Hospital in September 2020 to February 2021. A total of 60 participants will be recruited for the study (30 in each arm), who will be randomized into the synbiotic arm or the placebo arm. Both investigators and patients will be blinded to the treatment, and blinding will be conducted by the pharmacy unit of Dr. Cipto Mangunkusumo General Hospital.

Patients who had consented to participate will be assessed for medical history and physical examination. Food recall evaluation will also be performed by a nutritionist. Blood samples will be collected from the patient for laboratory examinations, including haemoglobin, white blood cells (WBC), platelet, urea, creatinine, albumin, and indoxyl sulfate. Patients will also be asked to complete two questionnaires: the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire to assess the symptoms of constipation and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire to assess constipation-related quality of life. After this, patients will be randomized into one of the two study arms. The data will serve as baseline data.

Patients will receive 2 capsules containing either synbiotics or placebo per day for the next 30 days. Afterwards, the patients will undergo examination to evaluate food recall and side effects. After evaluation, the patients will once again receive 2 capsules containing either synbiotics or placebo per day for the next 30 days, and after a total 2 months of interventions, will undergo examinations similar to that done in baseline examination.

The primary outcome of this study is the concentration of indoxyl sulfate in end-stage renal disease patients undergoing hemodialysis. Secondary outcomes include the symptoms of constipation and constipation-related quality of life in end-stage renal disease patients undergoing hemodialysis.

This study will be done according to the principles detailed in Helsinki declaration, Guideline for Good Clinical Practice from ICH Tripartite Guideline (ICH-GCP), and had been approved by the Ethical Committee of the Faculty of Medicine of Indonesia University.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a double-blind, placebo-controlled, randomized clinical trial conducted on end-stage renal disease patients undergoing hemodialysis. Patients will be randomized into two arms: symbiotic and placebo. The study will take place in the hemodialysis unit of Dr. Cipto Mangunkusumo General Hospital in September 2020 to February 2021. A total of 60 participants will be recruited for the study (30 in each arm). Both investigators and patients will be blinded to the treatment, and blinding will be conducted by the pharmacy unit of Dr. Cipto Mangunkusumo General Hospital.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Masking is done for participants, care provider, and investigator. Masking is assigned by the pharmacy unit of Dr. Cipto Mangunkusumo Hospital.
Primary Purpose: Supportive Care
Official Title: Effects of Synbiotics Supplementation on the Concentration of the Uremic Toxin Indoxyl Sulfate, Symptoms of Constipation, and Constipation-related Quality of Life in End-stage Renal Disease Patients Undergoing Hemodialysis
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Synbiotic Arm
Patients receiving synbiotics: Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 Colony Forming Unit (CFU) and Fructooligosaccharides (FOS) 60 mg, 2 capsules/day for 60 days
 Dietary Supplement: Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg
Patients will undergo baseline examination including medical history and physical examination, blood samples will be collected for hemoglobin, WBC, platelet, urea, creatinine, albumin and indoxyl sulfate level. Patients will be asked to complete 2 questionnaires the PAC-SYM and PAC-QOL questionnaires, and will undergo food recall evaluations by a nutritionist. They will then be given 2 capsules of synbiotics per day for 30 days. After 1 month of intervention, the patients will be evaluated for food recall and side effects. Afterwards, the patients will receive 2 capsules of the same synbiotics per day for the next 30 days. After 2 months of intervention, the patients' history will be taken, they will be asked to complete the PAC-SYM and PAC-QOL questionnaires, undergo food recall examination, and side effects evaluation. Blood samples will be taken for indoxyl sulfate examination.
Placebo Comparator: Placebo Arm
Patients receiving placebo capsules containing saccharum lactis (2 capsules/day for 60 days)
 Other: Placebo
Patients will undergo baseline examination including medical history and physical examination, blood samples will be collected for hemoglobin, WBC, platelet, urea, creatinine, albumin and indoxyl sulfate level. Patients will be asked to complete 2 questionnaires the PAC-SYM and PAC-QOL questionnaires, and will undergo food recall evaluations by a nutritionist. They will then be given 2 capsules of placebo per day for 30 days. After 1 month of intervention, the patients will be evaluated for food recall and side effects. Afterwards, the patients will receive 2 capsules of the same placebo per day for the next 30 days. After 2 months of intervention, the patients' history will be taken, they will be asked to complete the PAC-SYM and PAC-QOL questionnaires, undergo food recall examination, and side effects evaluation. Blood samples will be taken for indoxyl sulfate examination.


Outcome Measures
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Primary Outcome Measures :
  1. Indoxyl Sulfate concentration [ Time Frame: Through study completion, an average of 60 days ]
    Concentration of indoxyl sulfates in the subjects' blood samples


Secondary Outcome Measures :
  1. Symptoms of constipation [ Time Frame: Through study completion, an average of 60 days ]
    Constipation-related symptoms as assessed using Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Score will be assessed at the start and at the end of the study. Symptoms will be considered improved if there is a reduction of total score by 1 or more point(s).

  2. Constipation-related quality of life [ Time Frame: Through study completion, an average of 60 days ]
    Constipation-related quality of life as assessed using Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. Score will be assessed at the start and at the end of the study. Quality of life will be considered improved if there is a reduction of total score by 1 or more point(s).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged more than 18 years old
  • Had undergone hemodialysis twice a week for a minimum of 3 months, with each visit lasting 5 hours
  • Had only undergone hemodialysis therapy (not peritoneal dialysis/kidney transplantation)
  • No history of malignancy or undergoing chemotherapy/radiation therapy
  • No history of autoimmune disease or consuming immunosuppressants
  • No history of bowel resection
  • Had never been diagnosed with Crohn's disease or ulcerative colitis

Exclusion Criteria:

  • Patients whose hemodialysis schedule was changed from twice a week to three times a week
  • Patients consuming prebiotics/probiotics/synbiotics within the past 3 weeks
  • Patients experiencing infection or is consuming antibiotics
  • Patients who are not willing to participate
Contacts and Locations
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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): NCT04527640


Contacts
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Contact: Aida Lydia, MD, PhD +62 812-102-8939 draidalydia@gmail.com
Contact: Tities Indra, MD +62 8111-288-300 drtities@gmail.com

Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Aida Lydia, MD, PhD Indonesia University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Aida Lydia, PhD, SpPD-KGH, Teaching Staff, Faculty of Medicine, Indonesia University; Head of Kidney & Hypertension Division, Faculty of Medicine, Indonesia University, Indonesia University
ClinicalTrials.gov Identifier: NCT04527640    
Other Study ID Numbers: 20-07-0796
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Aida Lydia, PhD, SpPD-KGH, Indonesia University:
Synbiotics
Indoxyl Sulfate
Constipation
Quality of life
 Dysbiosis
End-Stage Renal Disease
Hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Constipation
Signs and Symptoms, Digestive
 Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency