Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease

NCT07430280 | Not Yet Recruiting

• 1 other identifier: CHMH-SYNBIO-2026
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Disease; Inflammation

Keywords

Synbiotic; Gut microbiota; Predialysis; Nutrition intervention

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

Synbiotic Group

EXPERIMENTAL

Participants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks.

Dietary Supplement: Synbiotic Supplement

Placebo Group

PLACEBO COMPARATOR

Participants assigned to this arm will receive a placebo identical in appearance and administration to the synbiotic for 16 weeks.

Other: Placebo

Interventions

Synbiotic Supplement DIETARY_SUPPLEMENT

Oral synbiotic supplement administered once daily for 16 weeks.

Synbiotic Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centenario Hospital Miguel Hidalgo: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, care providers, investigators, and outcome assessors will be blinded to group assignment. The synbiotic and placebo will be identical in appearance, packaging, and administration to maintain blinding throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a parallel design to one of two study arms. One group will receive a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans, while the other group will receive a placebo. Each participant will remain in the assigned intervention group for the entire 16-week study period.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02