Clinical trial NCT05934552: Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients
Official title: Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. group A (50 PT DM and Non DM CKD Stage 3,4,5 not ON dialysis and receive lactulose 30 ml per day divided in 3 doses
2. -group B (50 patients DM and Non DM CKD stage 3.4,5 not on dialysis and receive lactobacillus acidophilus one tab twice daily
3. Group C control group (50 PT DM and Non DM CKD stage 3,4,5 not on dialysis and receive neither lactulose ,nor lactobacillus acidophilus .

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tayebi Khosroshahi H, Habibzadeh A, Khoshbaten M, Rahbari B, Chaichi P, Badiee AH. Lactulose for reduction of nitrogen products in patients with chronic kidney disease. Iran J Kidney Dis. 2014 Sep;8(5):377-81.
citation: Tayebi-Khosroshahi H, Habibzadeh A, Niknafs B, Ghotaslou R, Yeganeh Sefidan F, Ghojazadeh M, Moghaddaszadeh M, Parkhide S. The effect of lactulose supplementation on fecal microflora of patients with chronic kidney disease; a randomized clinical trial. J Renal Inj Prev. 2016 Jul 29;5(3):162-7. doi: 10.15171/jrip.2016.34. eCollection 2016.