Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Not yet recruiting

• Conditions: CKD

• Registration Number: NCT05934552
• Lead Sponsor: Assiut University

Brief Summary

Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters of CKD as GFR, UREA ,CREATININE, CLINICAL and UREMIC assessment (lower limb edema ,UOP,base of chest ,vomiting ,dyspnea,blood pressure measurement)

Detailed Description

with advanced CKD stages ,also have been linked to the high prevalence of constipation in CKD,Lactulose is a synthetic disaccharide.Lactulose is poorly absorbed from the gastrointestinal tract remains virtually unchanged and is then fermented by gut microbiota that increase osmotic effects and intraluminal gas formation . lactulose reduces the nitrogen products and urea, creatinine, uric acid, and b2- microglobulin levels. Lactulose also suppress tubulointerstitial fibrosis in a rat model of a kidney disease study . Lactulose modifies the gut microbiota, increasing the abundance of Bifidobacteria and Lactobacilli after 8 weeks of 30 ml lactulose syrup thrice daily, and ameliorates CKD progression by suppressing uremic toxin production .probiotics include vast array of products with living organisms whose purpose is to improve intestinal microbial balance and produce beneficial effect on ones health .probiotics is an alternative therapy for patients with CKD

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Study Start: 2023-12
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• CKD stages 3,4,5 with non-dialysis receiving a diagnosis of constipation
• DM nephropathy

Exclusion Criteria

• IBS (ulcerative colitis -crohns)
• HCV ,HBV ,
• autoimmune patients,
• malignancy pt
• cirrhotic patients
• haemodialysis patients
• cardiovascular patients
• abdominal surgery,
• gut obstruction,
• pregnancy,
• patients with ESRD on dialysis,
• history of lactulose allergy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.	1 year	Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.