Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

CKD Clinical Trial

Official title:

Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934552
• Other study ID #: lactulose in CKD patients .
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: abdelrahamn abo bakr mokhtar, resident doctor
• Phone: +2001010180714
• Email: abdousaad95[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• CKD

Intervention

Drug:
• Lactulose
lactulose and lactobacillus acidophilus on ckd patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.	Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.	1 year