Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05934552
Collaborator
(none)
150
12

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdelrahman abobakr mokhtar, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05934552
Other Study ID Numbers:
  • lactulose in CKD patients .
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023