Probiotic and Synbiotic Supplements in Hemodialysis Patients

NCT07531186 | Completed

• 1 other identifier: MS.23.02.2301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized controlled trial evaluated the effects of natural probiotic and synbiotic supplementation on clinical and biochemical characteristics in adults with end-stage renal disease receiving maintenance hemodialysis at the Urology and Nephrology Center, Mansoura University, Egypt. Participants were randomized into three groups (control, probiotic, and synbiotic), with supplementation given for 6 months in the intervention groups. The study assessed changes in uremic toxins (including p-cresyl sulfate) as the primary outcome, and cardiovascular parameters, quality of life, and cognitive function as secondary outcomes. The trial aimed to determine whether modulation of gut microbiota with probiotics or synbiotics can improve outcomes in hemodialysis patients

Conditions

End Stage Renal Disease (ESRD); Kidney Failure, Chronic; Hemodialysis

Keywords

Probiotic; Synbiotic; Hemodialysis; Uremic toxins; p-Cresyl sulfate; Gut microbiota; End stage renal disease; Quality of life; Cognitive function; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Serum p-Cresyl Sulfate (PCS)

  Serum p-cresyl sulfate level is measured in blood. Outcome is the change from baseline to the end of the intervention.

  Baseline and 6 months

Secondary Outcomes (11)

• Change in Quality of Life (Kidney Disease Quality of Life-36)

  Baseline and 6 months

• Change in Cognitive Function (Montreal Cognitive Assessment)

  Baseline and 6 months

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline and 6 months

• Change in Left Ventricular End-Diastolic Volume (LVEDV)

  Baseline and 6 months

• Change in Left Ventricular End-Systolic Volume (LVESV)

  Baseline and 6 months

Study Arms (3)

Control (Standard Hemodialysis Care)

NO INTERVENTION

Participants received standard maintenance hemodialysis care without probiotic or synbiotic supplementation for the study period.

Probiotic Supplementation

EXPERIMENTAL

Participants received natural probiotic supplementation in addition to standard maintenance hemodialysis care for 6 months.

Dietary Supplement: Natural Probiotic Supplement

Synbiotic Supplementation

EXPERIMENTAL

Participants received synbiotic supplementation (natural probiotic plus prebiotic fiber \[oat\]) in addition to standard maintenance hemodialysis care for 6 months.

Dietary Supplement: Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)

Interventions

Natural Probiotic Supplement DIETARY_SUPPLEMENT

Oral natural probiotic supplementation was administered in addition to standard maintenance hemodialysis care for 6 months.

Probiotic Supplementation

Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber) DIETARY_SUPPLEMENT

Oral synbiotic supplementation (natural probiotic plus prebiotic fiber \[oat\]) was administered in addition to standard maintenance hemodialysis care for 6 months.

Synbiotic Supplementation

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• End-stage renal disease patients on regular maintenance hemodialysis
• Not under active preparation for kidney transplantation within the next year (i.e., not planned for transplantation for more than one year)

You may not qualify if:

• Age less than 18 years
• Under active preparation for kidney transplantation
• Pregnancy
• Active malignancy
• Known structural gastrointestinal tract disease

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center (UNC), Mansoura University

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Related Publications (4)

• Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.

  PMID: 24231662 RESULT

• Chen YY, Chen DQ, Chen L, Liu JR, Vaziri ND, Guo Y, Zhao YY. Microbiome-metabolome reveals the contribution of gut-kidney axis on kidney disease. J Transl Med. 2019 Jan 3;17(1):5. doi: 10.1186/s12967-018-1756-4.

  PMID: 30602367 RESULT

• Nguyen TTU, Kim HW, Kim W. Effects of Probiotics, Prebiotics, and Synbiotics on Uremic Toxins, Inflammation, and Oxidative Stress in Hemodialysis Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 Sep 28;10(19):4456. doi: 10.3390/jcm10194456.

  PMID: 34640474 RESULT

• Liu S, Liu H, Chen L, Liang SS, Shi K, Meng W, Xue J, He Q, Jiang H. Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial. Eur J Nutr. 2020 Dec;59(8):3755-3766. doi: 10.1007/s00394-020-02207-2. Epub 2020 Feb 28.

  PMID: 32112136 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind randomized trial. Outcome assessors were blinded to group assignment. Echocardiography was performed and interpreted by cardiologists who were unaware of the intervention allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Resident

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 15, 2026
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 5, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)