Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

NCT ID: NCT05934552

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-12-31

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

Conditions

CKD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Lactulose

lactulose and lactobacillus acidophilus on ckd patients

Intervention Type: DRUG

Other Intervention Names

lactobacillus acidophilus

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman abobakr mokhtar

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

abdelrahamn abo bakr mokhtar, resident doctor

Role: CONTACT

abdousaad95@gmail.com

+2001010180714

References

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.

Reference Type: BACKGROUND

PMID: 25194404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27689115 (View on PubMed)

Other Identifiers

lactulose in CKD patients .

Identifier Type: -

Identifier Source: org_study_id