Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
72 (estimated)
Sponsor
Mansoura University · Other
Who this trial is looking for
This trial is looking for adults with moderate to severe chronic kidney disease. Participants will take either probiotics or a placebo for 6 months and attend check-ups to monitor their kidney health and any side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with Chronic Kidney Disease Stage III or IV.
I am in stable health with no recent serious illnesses.
I am not currently taking probiotics or prebiotics.
I am willing to provide informed consent.
I can attend all required clinic visits and provide samples.
You may not be able to join if
I have CKD Stage I, II, or V, or I am on dialysis.
I am currently using probiotics or prebiotics.
I have a history of active cancer or am undergoing chemotherapy.
I have significant gastrointestinal disease.
I am pregnant or breastfeeding.
I have an autoimmune disease.
I take long-term antibiotics or anti-inflammatory medications.
I have severe behavioral or cognitive disorders.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical trial is to learn whether probiotic supplementation can slow disease progression in patients with moderate to severe chronic kidney disease (CKD). The trial will also assess the safety of probiotics in these patients.
The main questions the study aims to answer are:
Does probiotic supplementation improve kidney function by reducing serum creatinine levels and protein in…
The goal of this clinical trial is to learn whether probiotic supplementation can slow disease progression in patients with moderate to severe chronic kidney disease (CKD). The trial will also assess the safety of probiotics in these patients.
The main questions the study aims to answer are:
Does probiotic supplementation improve kidney function by reducing serum creatinine levels and protein in urine? Does it reduce inflammation and metabolic imbalances in CKD patients? Does it affect gut microbiota composition and lower harmful toxins in the body? Is probiotic supplementation safe and well-tolerated in CKD patients?
Participants will:
Be randomly assigned to receive either probiotics or a placebo for 6 months. Have clinic visits every 6 months for checkups, blood tests, and urine tests. Be monitored for any side effects and changes in kidney function. Researchers will compare the probiotic group to the placebo group to determine whether probiotics are effective in slowing CKD progression.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults aged ≥ 18 years (both males and females).
* Diagnosed with Chronic Kidney Disease (CKD) Stage III or IV, confirmed by eGFR.
* Stable medical condition with no recent hospitalization for acute kidney injury or other serious illnesses.
* Not currently on probiotic supplem…
Inclusion Criteria:
* Adults aged ≥ 18 years (both males and females).
* Diagnosed with Chronic Kidney Disease (CKD) Stage III or IV, confirmed by eGFR.
* Stable medical condition with no recent hospitalization for acute kidney injury or other serious illnesses.
* Not currently on probiotic supplementation or prebiotic therapy.
* Willing to provide informed consent and comply with the study protocol, including clinic visits and sample collection.
Exclusion Criteria:
* CKD Stage I, II, or V, or on dialysis.
* Currently using probiotics or prebiotics as part of their diet or treatment.
* History of active malignancy (cancer) or undergoing chemotherapy.
* Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery).
* Pregnant or breastfeeding women (due to safety concerns).
* Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis).
* Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition.
* Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol.
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