Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients (NCT07694791) | Clinical Trial Compass
RecruitingNot Applicable
Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients
Mexico60 participantsStarted 2025-10-03
Plain-language summary
The goal of this clinical trial is to learn if synbiotics work to lower inflammation in adults with chronic kidney disease who are on peritoneal dialysis. Synbiotics are daily capsules that contain a mix of probiotics (good bacteria) and prebiotics (fiber that feeds good bacteria).
The main questions it aims to answer are:
Do synbiotics lower the level of inflammation markers in the blood? Do synbiotics improve the nutritional status of the participants? Do synbiotics lower the number of peritonitis (peritoneal infections) episodes?
Researchers will compare synbiotics to a placebo to see if the treatment works. A placebo is a look-alike capsule that contains no active ingredients. Participants will:
Take 1 capsule every day for 6 months Visit the clinic at the start, at 3 months, and at 6 months for blood tests and nutrition checkups
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or older.
* Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.
Exclusion Criteria:
* Patients who are unable to eat or receive food through a feeding tube.
* Patients who have taken prebiotics or probiotics (supplements that support gut health) in the month before the study starts.
* Patients who used antibiotics in the month before the study starts.
* Patients who cannot attend the scheduled follow-up visits (missing the second follow-up appointment will result in being removed from the study).
* Note on non-adherence and withdrawal: Patients who are unable to take their assigned capsules regularly (taking less than 80% of the total capsules will result in being removed from the study).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
Timeframe: Baseline (Month 0), Month 3, and Month 6.
2
Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months.
Timeframe: Baseline (Month 0), Month 3, and Month 6.
3
Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months.
Timeframe: Baseline (Month 0), Month 3, and Month 6.
4
Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months.
Timeframe: Baseline (Month 0), Month 3, and Month 6.
Trial details
NCT IDNCT07694791
SponsorHospital Universitario Dr. Jose E. Gonzalez