Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease (SSIPCKD)

February 24, 2026 updated by: Centenario Hospital Miguel Hidalgo

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synbiotic Group
Participants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks.
Dietary supplement: Synbiotic Supplement
Oral synbiotic supplement administered once daily for 16 weeks.
Placebo Comparator: Placebo Group
Participants assigned to this arm will receive a placebo identical in appearance and administration to the synbiotic for 16 weeks.
Other: Placebo
Placebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centenario Hospital Miguel Hidalgo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMH-SYNBIO-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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