ConstipationNCT04527640
Effects of Synbiotics Supplementation on the Uremic Toxin Indoxyl Sulfate Level and Constipation in End-stage Renal Disease Patients Undergoing Hemodialysis
A study testing Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg in people with Constipation and End Stage Renal Disease on Dialysis, run by Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, End Stage Renal Disease on Dialysis
- What is being tested?
- Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Constipation, End Stage Renal Disease on Dialysis
- Being tested
- Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg, Placebo
- Keywords
- Synbiotics, Indoxyl Sulfate, Constipation, Quality of life, Dysbiosis, End-Stage Renal Disease, Hemodialysis
- Medical subject headings
- Constipation, Dysbiosis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mgDietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Arm | Experimental | Patients receiving synbiotics: Lactobacillus acidophilus \& Bifidobacterium longum 5x10^9 Colony Forming Unit (CFU) and Fructooligosaccharides (FOS) 60 mg, 2 capsules/day for 60 days Receives: Dietary Supplement: Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg |
| Placebo Arm | Placebo comparator | Patients receiving placebo capsules containing saccharum lactis (2 capsules/day for 60 days) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoxyl Sulfate concentration
Concentration of indoxyl sulfates in the subjects' blood samples
Measured: Through study completion, an average of 60 days
Secondary outcomes (2)
Symptoms of constipation
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).
Measured: Through study completion, an average of 60 days
Constipation-related quality of life
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).
Measured: Through study completion, an average of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start15 Sep 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aida Lydia, PhD, SpPD-KGH, Universitas Indonesia
- Investigators
- Aida Lydia, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527640
- Sponsor's protocol ID
- 20-07-0796
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Publications
Said S, Hernandez GT. The link between chronic kidney disease and cardiovascular disease. J Nephropathol. 2014 Jul;3(3):99-104. doi: 10.12860/jnp.2014.19. Epub 2014 Jul 1.
PubMed 25093157Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, Hobbs FD. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765. doi: 10.1371/journal.pone.0158765. eCollection 2016.
PubMed 27383068Hasan M, Sutradhar I, Gupta RD, Sarker M. Prevalence of chronic kidney disease in South Asia: a systematic review. BMC Nephrol. 2018 Oct 23;19(1):291. doi: 10.1186/s12882-018-1072-5.
PubMed 30352554Khan YH, Mallhi TH, Sarriff A, Khan AH, Tanveer N. Prevalence of Chronic Kidney Disease in Asia: A Systematic Review of Population-Based Studies. J Coll Physicians Surg Pak. 2018 Dec;28(12):960-966. doi: 10.29271/jcpsp.2018.12.960.
PubMed 30501836Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, Zhao MH, Lv J, Garg AX, Knight J, Rodgers A, Gallagher M, Kotwal S, Cass A, Perkovic V. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015 May 16;385(9981):1975-82. doi: 10.1016/S0140-6736(14)61601-9. Epub 2015 Mar 13.
PubMed 25777665Liu M, Li XC, Lu L, Cao Y, Sun RR, Chen S, Zhang PY. Cardiovascular disease and its relationship with chronic kidney disease. Eur Rev Med Pharmacol Sci. 2014 Oct;18(19):2918-26.
PubMed 25339487Tong J, Liu M, Li H, Luo Z, Zhong X, Huang J, Liu R, He F, Fu J. Mortality and Associated Risk Factors in Dialysis Patients with Cardiovascular Disease. Kidney Blood Press Res. 2016;41(4):479-87. doi: 10.1159/000443449. Epub 2016 Jul 20.
PubMed 27434642Kendrick J, Chonchol MB. Nontraditional risk factors for cardiovascular disease in patients with chronic kidney disease. Nat Clin Pract Nephrol. 2008 Dec;4(12):672-81. doi: 10.1038/ncpneph0954. Epub 2008 Sep 30.
PubMed 18825155Allon M. Evidence-based cardiology in hemodialysis patients. J Am Soc Nephrol. 2013 Dec;24(12):1934-43. doi: 10.1681/ASN.2013060632. Epub 2013 Oct 17.
PubMed 24136920Wong J, Piceno YM, DeSantis TZ, Pahl M, Andersen GL, Vaziri ND. Expansion of urease- and uricase-containing, indole- and p-cresol-forming and contraction of short-chain fatty acid-producing intestinal microbiota in ESRD. Am J Nephrol. 2014;39(3):230-237. doi: 10.1159/000360010. Epub 2014 Mar 8.
PubMed 24643131Zuvela J, Trimingham C, Le Leu R, Faull R, Clayton P, Jesudason S, Meade A. Gastrointestinal symptoms in patients receiving dialysis: A systematic review. Nephrology (Carlton). 2018 Aug;23(8):718-727. doi: 10.1111/nep.13243.
PubMed 29468835Sumida K, Yamagata K, Kovesdy CP. Constipation in CKD. Kidney Int Rep. 2019 Nov 13;5(2):121-134. doi: 10.1016/j.ekir.2019.11.002. eCollection 2020 Feb.
PubMed 32043026Zhang J, Huang C, Li Y, Chen J, Shen F, Yao Q, Qian J, Bao B, Yao X. Health-related quality of life in dialysis patients with constipation: a cross-sectional study. Patient Prefer Adherence. 2013 Jun 18;7:589-94. doi: 10.2147/PPA.S45471. Print 2013.
PubMed 23814466Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.
PubMed 26590448Claro LM, Moreno-Amaral AN, Gadotti AC, Dolenga CJ, Nakao LS, Azevedo MLV, de Noronha L, Olandoski M, de Moraes TP, Stinghen AEM, Pecoits-Filho R. The Impact of Uremic Toxicity Induced Inflammatory Response on the Cardiovascular Burden in Chronic Kidney Disease. Toxins (Basel). 2018 Sep 23;10(10):384. doi: 10.3390/toxins10100384.
PubMed 30249039
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04527640
- Acronym / sponsor ID
- 20-07-0796
- Conditions
- Constipation, End Stage Renal Disease on Dialysis
- Keywords
- Synbiotics, Indoxyl Sulfate, Constipation, Quality of life, Dysbiosis, End-Stage Renal Disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Arm | Experimental | Dietary Supplement: Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mgPatients receiving synbiotics: Lactobacillus acidophilus \& Bifidobacterium longum 5x10^9 Colony Forming Unit (CFU) and Fructooligosaccharides (FOS) 60 mg, 2 capsules/day for 60 days |
| Placebo Arm | Placebo comparator | Other: PlaceboPatients receiving placebo capsules containing saccharum lactis (2 capsules/day for 60 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mgPatients 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. | Dietary supplement | Synbiotic Arm |
| PlaceboPatients 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. | Other | Placebo Arm |
Primary outcome
Indoxyl Sulfate concentration
Time frame: Through study completion, an average of 60 days
Concentration of indoxyl sulfates in the subjects' blood samples
2 secondary outcomes
Symptoms of constipation
Time frame: Through study completion, an average of 60 days
Constipation-related quality of life
Time frame: Through study completion, an average of 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 25093157Said S, Hernandez GT. The link between chronic kidney disease and cardiovascular disease. J Nephropathol. 2014 Jul;3(3):99-104. doi: 10.12860/jnp.2014.19. Epub 2014 Jul 1.
- Background: PubMed 27383068Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, Hobbs FD. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765. doi: 10.1371/journal.pone.0158765. eCollection 2016.
- Background: PubMed 30352554Hasan M, Sutradhar I, Gupta RD, Sarker M. Prevalence of chronic kidney disease in South Asia: a systematic review. BMC Nephrol. 2018 Oct 23;19(1):291. doi: 10.1186/s12882-018-1072-5.
- Background: PubMed 30501836Khan YH, Mallhi TH, Sarriff A, Khan AH, Tanveer N. Prevalence of Chronic Kidney Disease in Asia: A Systematic Review of Population-Based Studies. J Coll Physicians Surg Pak. 2018 Dec;28(12):960-966. doi: 10.29271/jcpsp.2018.12.960.
- Background: PubMed 25777665Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, Zhao MH, Lv J, Garg AX, Knight J, Rodgers A, Gallagher M, Kotwal S, Cass A, Perkovic V. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015 May 16;385(9981):1975-82. doi: 10.1016/S0140-6736(14)61601-9. Epub 2015 Mar 13.
- Background: PubMed 25339487Liu M, Li XC, Lu L, Cao Y, Sun RR, Chen S, Zhang PY. Cardiovascular disease and its relationship with chronic kidney disease. Eur Rev Med Pharmacol Sci. 2014 Oct;18(19):2918-26.
- Background: PubMed 27434642Tong J, Liu M, Li H, Luo Z, Zhong X, Huang J, Liu R, He F, Fu J. Mortality and Associated Risk Factors in Dialysis Patients with Cardiovascular Disease. Kidney Blood Press Res. 2016;41(4):479-87. doi: 10.1159/000443449. Epub 2016 Jul 20.
- Background: PubMed 18825155Kendrick J, Chonchol MB. Nontraditional risk factors for cardiovascular disease in patients with chronic kidney disease. Nat Clin Pract Nephrol. 2008 Dec;4(12):672-81. doi: 10.1038/ncpneph0954. Epub 2008 Sep 30.
- Background: PubMed 24136920Allon M. Evidence-based cardiology in hemodialysis patients. J Am Soc Nephrol. 2013 Dec;24(12):1934-43. doi: 10.1681/ASN.2013060632. Epub 2013 Oct 17.
- Background: PubMed 24643131Wong J, Piceno YM, DeSantis TZ, Pahl M, Andersen GL, Vaziri ND. Expansion of urease- and uricase-containing, indole- and p-cresol-forming and contraction of short-chain fatty acid-producing intestinal microbiota in ESRD. Am J Nephrol. 2014;39(3):230-237. doi: 10.1159/000360010. Epub 2014 Mar 8.
- Background: PubMed 29468835Zuvela J, Trimingham C, Le Leu R, Faull R, Clayton P, Jesudason S, Meade A. Gastrointestinal symptoms in patients receiving dialysis: A systematic review. Nephrology (Carlton). 2018 Aug;23(8):718-727. doi: 10.1111/nep.13243.
- Background: PubMed 32043026Sumida K, Yamagata K, Kovesdy CP. Constipation in CKD. Kidney Int Rep. 2019 Nov 13;5(2):121-134. doi: 10.1016/j.ekir.2019.11.002. eCollection 2020 Feb.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida Lydia, MD, PhD principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg in people with Constipation and End Stage Renal Disease on Dialysis, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Lydia, MD, PhD (+62 812-102-8939, draidalydia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indoxyl Sulfate concentration (time frame: Through study completion, an average of 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527640, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.