Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

NCT05934552 | Unknown

• 1 other identifier: lactulose in CKD patients .
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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)

Conditions

CKD

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Lactulose DRUG

lactulose and lactobacillus acidophilus on ckd patients

Also known as: lactobacillus acidophilus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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 .

You may qualify if:

• CKD stages 3,4,5 with non-dialysis receiving a diagnosis of constipation
• DM nephropathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 25194404 BACKGROUND

• 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.

  PMID: 27689115 BACKGROUND

MeSH Terms

Interventions

Lactulose; Lacteol

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

abdelrahamn abo bakr mokhtar, resident doctor

CONTACT

+2001010180714; abdousaad95@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 7, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-06