[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582429":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nThe 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.\n\nParticipants 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).",[13],"Drug: Probiotic Supplementation (Lactobacillus plantarum)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.\n\nThis 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.\n\nOutcomes 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.",null,[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Probiotic Supplementation (Lactobacillus plantarum)","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.\n\nThis 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.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":18,"otherNames":18},"Placebo Tablets","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.\n\nThe 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.",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Samar Elshahat Saleh","CONTACT","00201023771331","samarelshahat@mans.edu.eg",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Urology and Nephrology Center, Mansoura University","RECRUITING","Al Mansurah","Dakahliya","35111","Egypt","EG",{"type":44,"coordinates":45},"Point",[46,47],31.38069,31.03637,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":18,"email":33},"Samar E Saleh","+201023771331",{"type":54,"investigatorFullName":30,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100582429","phase-1-probiotic-supplementation-and-disease-progression-in-ckd-a-randomized-trial-100582429",false,"NCT06863194","Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial","Effects of Probiotic Supplementation on Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease: A Randomized Controlled Trial","PRO-CKD","Inclusion Criteria:\n\n* Adults aged ≥ 18 years (both males and females).\n* Diagnosed with Chronic Kidney Disease (CKD) Stage III or IV, confirmed by eGFR.\n* Stable medical condition with no recent hospitalization for acute kidney injury or other serious illnesses.\n* Not currently on probiotic supplementation or prebiotic therapy.\n* Willing to provide informed consent and comply with the study protocol, including clinic visits and sample collection.\n\nExclusion Criteria:\n\n* CKD Stage I, II, or V, or on dialysis.\n* Currently using probiotics or prebiotics as part of their diet or treatment.\n* History of active malignancy (cancer) or undergoing chemotherapy.\n* Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery).\n* Pregnant or breastfeeding women (due to safety concerns).\n* Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis).\n* Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition.\n* Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol.","ALL","18 Years",{"count":67,"type":68},72,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","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.\n\nThe main questions the study aims to answer are:\n\nDoes 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?\n\nParticipants will:\n\nBe 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.",[75,76,77,78],"Kidney Disease, Chronic","Renal Insufficiency, Chronic","Gut Dysbiosis","Uremic Toxins",[80,81,82,78,83,84,85,86],"Chronic Kidney Disease (CKD)","Probiotics","Gut Microbiota","Indoxyl Sulfate (IS)","Inflammation in CKD","Dysbiosis in CKD","Lactobacillus plantarum","2025-05-13",{"date":89,"type":90},"2025-05-16","ACTUAL",{"date":92,"type":90},"2025-04-03",{"date":94,"type":68},"2025-10-20",{"name":5,"class":6},1]