An interventional study of Synbiotic Supplement and Placebo in Chronic Kidney Disease and Inflammation, sponsored by Centenario Hospital Miguel Hidalgo. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Centenario Hospital Miguel Hidalgo · Not applicable, Interventional, and Treatment
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.
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Centenario Hospital Miguel Hidalgo is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks.
Dietary Supplement: Synbiotic Supplement
Participants assigned to this arm will receive a placebo identical in appearance and administration to the synbiotic for 16 weeks.
Other: Placebo
Oral synbiotic supplement administered once daily for 16 weeks.
Placebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks.
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.
Time frame: Baseline and at 16 weeks
No study locations are listed for this record.
Start is estimated for Mar 2026; primary completion for Mar 2026, 0 months later.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 0 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Synbiotic Supplement
Renal Insufficiency, Chronic →
Centenario Hospital Miguel Hidalgo