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New treatment option for Kidney Disease, Chronic
Official title Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
ClinicalTrials.gov ID: NCT06863194
What this study is testing
What is Probiotic Supplementation (Lactobacillus plantarum)?
Probiotic Supplementation (Lactobacillus plantarum) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for kidney disease, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahliya, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahliya, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.