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

NCT04527640 | Unknown

• 1 other identifier: 20-07-0796
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation; End Stage Renal Disease on Dialysis

Keywords

Synbiotics; Indoxyl Sulfate; Constipation; Quality of life; Dysbiosis; End-Stage Renal Disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Indoxyl Sulfate concentration

  Concentration of indoxyl sulfates in the subjects' blood samples

  Through study completion, an average of 60 days

Secondary Outcomes (2)

• Symptoms of constipation

  Through study completion, an average of 60 days

• Constipation-related quality of life

  Through study completion, an average of 60 days

Study Arms (2)

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

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)

Other: Placebo

Interventions

Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg DIETARY_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.

Synbiotic Arm

Placebo OTHER

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.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

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MeSH Terms

Conditions

Constipation; Dysbiosis; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Aida Lydia, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Lydia, MD, PhD

CONTACT

+62 812-102-8939; draidalydia@gmail.com

Tities Indra, MD

CONTACT

+62 8111-288-300; drtities@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking is done for participants, care provider, and investigator. Masking is assigned by the pharmacy unit of Dr. Cipto Mangunkusumo Hospital.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Staff, Faculty of Medicine, Indonesia University; Head of Kidney & Hypertension Division, Faculty of Medicine, Indonesia University

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 26, 2020
• Study Start: September 15, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 28, 2021
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share