Taking people in EgyptPhase 1/2

Tests a probiotic tablet in adults with chronic kidney disease

Tests whether a probiotic tablet affects kidney disease in adults with chronic kidney disease.

Key facts

Who runs it: Mansoura University
Where: Al Mansurah, EgyptSee the site
Trial code: NCT06863194
Registry title: Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Status: Recruiting
Phase: Phase 1/2
People taking part: 72 people, planned
Started: 3 Apr 2025
Planned end: 20 Oct 2025
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Probiotic Supplementation (Lactobacillus plantarum)
Placebo Tablets
Record updated: 16 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe chronic kidney disease (CKD stage III or IV) who are medically stable. It tests whether probiotics slow the disease.

Age: 18 years or older
Sex: Men and women
Disease stage: Chronic kidney disease stage III or IV, confirmed by eGFR
Earlier treatment: Must not be taking probiotic or prebiotic supplements. No recent hospital stay for acute kidney injury or other serious illness.

Main reasons for not taking part

CKD stage I, II or V, or on dialysis
Active cancer or chemotherapy
Significant gut disease, such as inflammatory bowel disease, irritable bowel syndrome or recent gut surgery
Pregnant or breastfeeding women
Autoimmune disease, such as lupus or rheumatoid arthritis

The registry criteria, word for word

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Who can take part

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

Who cannot take part

Currently using probiotics or prebiotics as part of their diet or treatment
Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition
History of active malignancy (cancer) or undergoing chemotherapy
Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery)
Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis)
Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol
CKD Stage I, II, or V, or on dialysis
Pregnant or breastfeeding women (due to safety concerns)

Where in Egypt

Urology and Nephrology Center, Mansoura UniversityAl Mansurah, EgyptContact: Samar E SalehTaking people

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

Arm 1 (Intervention Group) Arm Title: Probiotic Supplementation Group Description: Participants in tTreatment being tested
Participants in this group will receive Lactogemikan (Probiotic Supplement), which contains 10 billion CFU of Lactobacillus plantarum per tablet. They will take one tablet daily for 6 months. The purpose of this intervention is to evaluate whether probiotic supplementation can slow the progression of chronic kidney disease (CKD) by modulating gut microbiota, reducing systemic inflammation, and decreasing uremic toxin levels. Participants will be monitored through clinical visits and laboratory tests at baseline, and 6 months to assess kidney function (eGFR, serum creatinine, urinary protein levels), inflammatory markers (CRP, ferritin, albumin), and gut microbiota composition (urinary indican levels).
Treatment: Probiotic Supplementation (Lactobacillus plantarum)
Arm 2 (Control Group) Arm Title: Placebo Group Description: Participants in this group will receivePlacebo, for comparison
Participants in this group will receive a placebo tablet that is identical in appearance, taste, and packaging to the probiotic supplement but contains no active probiotic ingredients. They will take one tablet daily for 6 months. This group serves as a control to compare the effects of probiotic supplementation against a non-active intervention. Participants will undergo the same clinical visits and laboratory assessments as the intervention group at baseline, and 6 months. Outcomes assessed will include kidney function (eGFR, serum creatinine, urinary protein levels), systemic inflammation markers (CRP, ferritin, albumin), and gut microbiota composition (urinary indican levels) to determine whether the probiotic has a measurable impact compared to the placebo.