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Effect of Lactulose on Protein-Bound Uremic toxin Lowering in Pre-dialysis Chronic Kidney Disease patients: A Randomized controlled trial

Effect of Lactulose on Protein-Bound Uremic toxin Lowering in Pre-dialysis Chronic Kidney Disease patients: A Randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260212002
Enrollment
60
Registered
2026-02-12
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Constipation Chronic Kidney Disease Protein-Bound Uremic Toxins Indoxyl Sulfate p-Cresyl Sulfate Lactulose Sennosides

Interventions

Participants receive oral lactulose at a dose of 30 mL once daily at bedtime for 12 weeks. Lactulose acts as an osmotic laxative and prebiotic, aiming to reduce protein-bound uremic toxins in patients
Experimental Drug,Experimental Drug

Sponsors

Thai red cross society
Lead Sponsor
Faculty of medicine, Chulalongkorn university
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic kidney disease stage 4-5 who have not yet received renal replacement therapy 2. Presence of constipation, defined by the Bristol Stool Scale types 1-2 together with a bowel movement frequency of fewer than three times per week for at least three months.

Exclusion criteria

Exclusion criteria: 1. Use of lactulose or sennoside within the previous one month. 2. History of coronary artery disease. 3. Presence of liver cirrhosis. 4. History of bowel surgery or presence of short bowel syndrome. 5. Use of systemic antibiotics within the previous one month.

Design outcomes

Primary

MeasureTime frame
Protein-bound uremic toxins Baseline and Week 12 Change from baseline in serum indoxyl sulfate and p-cresyl sulfate measured by high-performance liquid chromatography

Secondary

MeasureTime frame
Change in estimated glomerular filtration rate Baseline and Week 12 Change from baseline in estimated glomerular filtration rate calculated using the CKD-EPI equation,Change in blood urea nitrogen Baseline and Week 12 Change from baseline in blood urea nitrogen measured by standard laboratory methods

Countries

Thailand

Contacts

Public ContactJarukit Kamnuanpol

Faculty of Medicine, Chulalongkorn University

jarukit.kam@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026