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End Stage Renal Disease (ESRD)NCT07531186

Probiotic and Synbiotic Supplements in Hemodialysis Patients

A study testing Natural Probiotic Supplement and Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber) in people with End Stage Renal Disease (ESRD) and Kidney Failure, Chronic, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 months and older
What is being tested?
Natural Probiotic Supplement and Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Mar 2025to 5 Oct 2025
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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Urology and Nephrology Center (UNC), Mansoura University

    Al Mansurah, Dakahlia Governorate, 35111

Other trials in Egypt

About this study

Official title: Effects of Probiotic and Synbiotic Administration on the Clinical and Biochemical Characteristics of Hemodialysis Patients: A Randomized Controlled Trial

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

Read the detailed description

End-stage renal disease patients receiving hemodialysis commonly have intestinal dysbiosis and accumulation of gut-derived uremic toxins. Probiotic and synbiotic supplementation may help modulate gut microbiota and reduce uremic toxin burden, but direct comparative data between probiotic and synbiotic strategies in hemodialysis patients are limited. This study was designed to assess the effects of natural probiotic and synbiotic administration on the clinical and biochemical characteristics and uremic toxin levels of hemodialysis patients at the Urology and Nephrology Center (UNC), Mansoura University, Egypt.

This was a single-center randomized controlled trial with single-blind allocation. Sixty adult patients with end-stage renal disease on regular hemodialysis were included (dropout-inflated sample size; calculated minimum sample size was 48). Participants were randomized into three groups: a control group (20 patients), a probiotic group (20 patients), and a synbiotic group (20 patients). The probiotic and synbiotic groups received supplementation for 6 months; the synbiotic intervention included natural probiotic supplementation combined with prebiotic fibers (oat). Regular hemodialysis was standardized during the trial (3 sessions/week, 4 hours/session).

The primary outcome was the effect of probiotic and synbiotic supplementation on uremic toxin levels, including p-cresyl sulfate. Secondary outcomes included cardiovascular-related parameters and comorbid clinical measures, including body mass index, anemia/ESA resistance, quality of life, and cognitive function. Assessments included laboratory testing (biochemical parameters and uremic toxins), echocardiographic evaluation by blinded cardiologists, and psychological assessment using cognitive testing (MOCA) and quality-of-life evaluation (KDQOL-36).

The completed thesis reports that both probiotic and synbiotic supplementation reduced serum p-cresyl sulfate compared with control, with a more pronounced reduction in the synbiotic group, and that some cardiovascular and quality-of-life parameters improved, while cognitive and other secondary outcomes were less pronounced. Baseline characteristics were comparable across groups, supporting successful randomization.

Being tested
Natural Probiotic Supplement, Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)
Keywords
Probiotic, Synbiotic, Hemodialysis, Uremic toxins, p-Cresyl sulfate, Gut microbiota, End stage renal disease, Quality of life, Cognitive function, Randomized controlled trial
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural Probiotic SupplementDietary supplement

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

  • 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.

Study groups in NCT07531186
Study groupRoleWhat they receive
Control (Standard Hemodialysis Care)No interventionParticipants received standard maintenance hemodialysis care without probiotic or synbiotic supplementation for the study period.
Probiotic SupplementationExperimentalParticipants received natural probiotic supplementation in addition to standard maintenance hemodialysis care for 6 months.
Receives: Dietary Supplement: Natural Probiotic Supplement
Synbiotic SupplementationExperimentalParticipants received synbiotic supplementation (natural probiotic plus prebiotic fiber [oat]) in addition to standard maintenance hemodialysis care for 6 months.
Receives: Dietary Supplement: Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 months

Secondary outcomes (11)

  1. Change in Quality of Life (Kidney Disease Quality of Life-36)

    Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire. Scores are reported for the KDQOL-36 subscales: Symptom/Problem List (0-100), Effects of Kidney Disease (0-100), and Burden of Kidney Disease (0-100), and the generic health components derived from the SF-12 (Physical Component Summary and Mental Component Summary). For the 0-100 KDQOL-36 subscales, higher scores indicate better quality of life (fewer symptoms/less burden). The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  2. Change in Cognitive Function (Montreal Cognitive Assessment)

    The Montreal Cognitive Assessment (MoCA) is a screening test of global cognitive function. Total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Outcome is a change in the MoCA total score from baseline to 6 months.

    Measured: Baseline and 6 months

  3. Change in Left Ventricular Ejection Fraction (LVEF)

    Left ventricular ejection fraction measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months. A higher percentage indicates better systolic function.

    Measured: Baseline and 6 months

  4. Change in Left Ventricular End-Diastolic Volume (LVEDV)

    Left ventricular end-diastolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  5. Change in Left Ventricular End-Systolic Volume (LVESV)

    Left ventricular end-systolic volume measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  6. Change in Left Ventricular Mass Index (LVMI)

    Left ventricular mass index measured by transthoracic echocardiography. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  7. Change in Blood Urea Nitrogen (BUN)

    Blood urea nitrogen is measured in blood. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  8. Change in Serum Creatinine

    Serum creatinine is measured in blood. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  9. Change in Serum Potassium

    Serum potassium is measured in blood. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  10. Change in Serum Phosphorus

    Serum phosphorus is measured in blood. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

  11. Change in Hemoglobin

    Hemoglobin is measured on a complete blood count. The outcome is the change from baseline to 6 months.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start1 Mar 2025
  3. Primary completion30 Sep 2025
  4. Study completion5 Oct 2025

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531186
Sponsor's protocol ID
MS.23.02.2301
Status last verified
Apr 2026
First submitted
28 Mar 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the dataset contains sensitive clinical information collected for a single-center academic thesis, and consent and local ethics approval did not include public IPD sharing. Aggregate results will be reported in the thesis and related publications.

Publications

  • 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.

    PubMed 24231662

  • 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.

    PubMed 30602367

  • 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.

    PubMed 34640474

  • 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.

    PubMed 32112136

Questions about this trial

What is this clinical trial studying?

A study testing Natural Probiotic Supplement and Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber) in people with End Stage Renal Disease (ESRD) and Kidney Failure, Chronic, run by Mansoura University at 1 site in Egypt.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum p-Cresyl Sulfate (PCS) (time frame: Baseline and 6 months). 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 NCT07531186, which also lists 4 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 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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