Chronic Kidney DiseaseSSIPCKDNCT07430280
Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease
A study testing Synbiotic Supplement in people with Chronic Kidney Disease and Inflammation, run by Centenario Hospital Miguel Hidalgo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Inflammation
- What is being tested?
- Synbiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Inflammation
- Being tested
- Synbiotic Supplement, Placebo
- Keywords
- Synbiotic, Gut microbiota, Predialysis, Nutrition intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic SupplementDietary supplement
Oral synbiotic supplement administered once daily for 16 weeks.
PlaceboOther
Placebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Group | Experimental | Participants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430280
- Sponsor's protocol ID
- CHMH-SYNBIO-2026
- Acronym
- SSIPCKD
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07430280
- Acronym / sponsor ID
- SSIPCKD / CHMH-SYNBIO-2026
- Conditions
- Chronic Kidney Disease, Inflammation
- Keywords
- Synbiotic, Gut microbiota, Predialysis, Nutrition intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centenario Hospital Miguel HidalgoUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Group | Experimental | Dietary Supplement: Synbiotic SupplementParticipants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants assigned to this arm will receive a placebo identical in appearance and administration to the synbiotic for 16 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic SupplementOral synbiotic supplement administered once daily for 16 weeks. | Dietary supplement | Synbiotic Group |
| PlaceboPlacebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks. | Other | Placebo Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Supplement in people with Chronic Kidney Disease and Inflammation, run by Centenario Hospital Miguel Hidalgo.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 High-Sensitivity C-Reactive Protein (hs-CRP) (time frame: Baseline and at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.