Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

June 28, 2023 updated by: Abdelrahman abobakr mokhtar, Assiut University
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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: abdelrahamn abo bakr mokhtar, resident doctor
  • Phone Number: +2001010180714
  • Email: abdousaad95@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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 .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.
Time Frame: 1 year
Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters in CKD patients and compare between both.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lactulose in CKD patients .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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