Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial

NCT06863194 | Recruiting Phase 1

• 1 other identifier: MD.24.06.864
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Disease, Chronic; Renal Insufficiency, Chronic; Gut Dysbiosis; Uremic Toxins

Keywords

Chronic Kidney Disease (CKD); Probiotics; Gut Microbiota; Uremic Toxins; Indoxyl Sulfate (IS); Inflammation in CKD; Dysbiosis in CKD; Lactobacillus plantarum

Outcome Measures

Primary Outcomes (1)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  eGFR will be calculated using the CKD-EPI 2021 equation to assess changes in kidney function over time. A slower decline in eGFR in the probiotic group compared to the placebo group would indicate a beneficial effect.

  Baseline, and 6 months

Secondary Outcomes (1)

• Change in Gut-Derived Uremic Toxins (Indoxyl Sulfate)

  Baseline, and 6 months

Study Arms (2)

Arm 1 (Intervention Group) Arm Title: Probiotic Supplementation Group Description: Participants in t

EXPERIMENTAL

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).

Drug: Probiotic Supplementation (Lactobacillus plantarum)

Arm 2 (Control Group) Arm Title: Placebo Group Description: Participants in this group will receive

PLACEBO COMPARATOR

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.

Interventions

Probiotic Supplementation (Lactobacillus plantarum) DRUG

Participants in this group will receive Lactogemikan (Probiotic Supplement), which contains 10 billion CFU of Lactobacillus plantarum per tablet. The dose is one tablet daily for 6 months. This probiotic is intended to modulate gut microbiota, reduce systemic inflammation, and decrease uremic toxins (indoxyl sulfate) in CKD patients. The intervention will be compared to a placebo to evaluate its effectiveness in slowing CKD progression and improving metabolic and inflammatory markers.

Arm 1 (Intervention Group) Arm Title: Probiotic Supplementation Group Description: Participants in t

Placebo Tablets DRUG

Participants in this group will receive an inert placebo tablet that is identical in appearance, taste, and packaging to the probiotic supplement but contains no active probiotic ingredients. The dose is one tablet daily for 6 months. The placebo serves as a control to compare the effects of the probiotic intervention. Both groups will undergo identical monitoring and follow-up assessments to determine whether the probiotic has a significant effect on kidney function, inflammation, and gut microbiota composition.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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).
• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, 35111, Egypt

RECRUITING

Related Publications (4)

• Seth A, Yan F, Polk DB, Rao RK. Probiotics ameliorate the hydrogen peroxide-induced epithelial barrier disruption by a PKC- and MAP kinase-dependent mechanism. Am J Physiol Gastrointest Liver Physiol. 2008 Apr;294(4):G1060-9. doi: 10.1152/ajpgi.00202.2007. Epub 2008 Feb 21.

  PMID: 18292183 BACKGROUND

• de Araujo EMR, Meneses GC, Carioca AAF, Martins AMC, Daher EF, Silva Junior GB. Use of probiotics in patients with chronic kidney disease on hemodialysis: a randomized clinical trial. J Bras Nefrol. 2023 Apr-Jun;45(2):152-161. doi: 10.1590/2175-8239-JBN-2022-0021en.

  PMID: 36112723 BACKGROUND

• Miranda Alatriste PV, Urbina Arronte R, Gomez Espinosa CO, Espinosa Cuevas Mde L. Effect of probiotics on human blood urea levels in patients with chronic renal failure. Nutr Hosp. 2014 Mar 1;29(3):582-90. doi: 10.3305/nh.2014.29.3.7179.

  PMID: 24559003 BACKGROUND

• Tian N, Li L, Ng JK, Li PK. The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease. Nutrients. 2022 Sep 29;14(19):4044. doi: 10.3390/nu14194044.

  PMID: 36235699 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samar Elshahat Saleh

CONTACT

00201023771331; samarelshahat@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: April 3, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 20, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)