Constipation Clinical Trial
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
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.
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.
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