Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease

Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to function properly. People with chronic kidney disease (CKD) often experience chronic inflammation and digestive symptoms that may affect their quality of life.

This study aims to evaluate whether daily supplementation with a synbiotic (a combination of probiotics and prebiotics) can reduce inflammation and improve gastrointestinal symptoms in adults with chronic kidney disease (CKD) stages 3 to 5 who are not receiving dialysis.

Participants will be randomly assigned to receive either a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans, or a placebo, for a total of 16 weeks. Blood tests will be performed to measure inflammation, and participants will complete questionnaires related to digestive symptoms, quality of life, and dietary habits.

The information obtained from this study may help improve nutritional strategies and supportive care for people living with chronic kidney disease.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Chronic kidney disease is associated with intestinal dysbiosis, increased intestinal permeability, endotoxemia, and chronic low-grade inflammation, which contribute to cardiovascular risk and reduced quality of life. Alterations in gut microbiota composition are influenced by uremia, dietary restrictions, reduced fiber intake, and medication use.

Synbiotics, which combine probiotics and prebiotics, have shown potential benefits in modulating gut microbiota, strengthening the intestinal barrier, and reducing systemic inflammation. However, evidence in patients with predialysis chronic kidney disease (CKD) remains limited.

This randomized, double-blind, parallel, placebo-controlled clinical trial will evaluate the effect of a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans on high-sensitivity C-reactive protein (hs-CRP) levels in adults with chronic kidney disease (CKD) stages 3 to 5 not receiving renal replacement therapy.

Participants will be randomly assigned to receive either the synbiotic or a placebo for 16 weeks. Secondary outcomes include gastrointestinal symptoms, kidney function, quality of life, nutritional knowledge, and dietary adherence. All participants will receive standardized nutritional counseling based on kidney disease outcomes quality initiative (KDOQI) clinical practice guidelines to ensure consistency between study groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 to 80 years.
Diagnosis of chronic kidney disease in pre-dialysis stages.
Stable clinical condition for at least 3 months prior to enrollment.
Ability to provide written informed consent.

Exclusion criteria

Current renal replacement therapy (hemodialysis or peritoneal dialysis).
Acute kidney injury.
Use of antibiotics, probiotics, prebiotics, or synbiotics within 4 weeks prior to enrollment.
Active infection, inflammatory disease, or malignancy.
Pregnancy or breastfeeding
Known intolerance or allergy to components of the synbiotic or placebo.

Treatment and study plan

Synbiotic Supplement

Dietary Supplement

Oral synbiotic supplement administered once daily for 16 weeks.

Placebo

Other

Placebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks.

Primary outcomes

Change in High-Sensitivity C-Reactive Protein (hs-CRP)

Time frame: Baseline and at 16 weeks

Change in serum high-sensitivity C-reactive protein (hs-CRP), measured in mg/L, comparing baseline and 16 weeks between the synbiotic and placebo groups.

Sponsors and collaborators

Lead sponsor

Centenario Hospital Miguel Hidalgo

Other

Registry information

Official study title

Effect of a Synbiotic Containing Lactobacillus Rhamnosus, Bifidobacterium Longum, and Agave Fructans on High-Sensitivity C-Reactive Protein Levels in Patients With Predialysis Chronic Kidney Disease: A Double-Blind, Placebo-Controlled Trial

Acronym: SSIPCKD

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 24, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed