A randomized study of lactulose versus sennoside for prevention of bacterial peritonitis in peritoneal dialysis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20171012001

Enrollment

Registered

2017-10-12

Start date

2017-06-06

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

Prevention of bacterial peritonitis in peritoneal dialysis patients Peritoneal dialysis Bacterial peritonitis Lactulose Sennoside

Interventions

Lactulose will be initiated at the dose of 15 ml per day keeping bowel movement from one time in two days to two times in a day. If the numbers of bowel movement is lower than expected&#44

lactulose will be increased 15 ml every 3 days until targeted bowel movement is achieved or the dose of lactulose achieves 45 ml per day. If the numbers of bowel movement is higher than expected&#44

lactulose will be reduced 15 ml per day until the dose of 15 ml per day is achieved&#44

after that&#44

the dose of lactulose will be reduced 5 ml per day&#44

,Sennoside will be initiated at the dose of 2 tablets per day keeping bowel movement from one time in two days to two times in a day. If the numbers of bowel movement is lower than expected&#44

sennoside will be increased 1 tablet everyday until targeted bowel movement is achieved or the dose of sennoside achieves 4 tablets per day. If the numbers of bowel movement is higher than expected&#4

sennoside will be reduced 1 tablet per day.

Experimental Drug,Active Comparator Drug

Lactulose,Sennoside

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Peritoneal dialysis patients who are 1. More than 15 years of age 2. Undergone peritoneal dialysis for more than 2 weeks

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent 2. History of bacterial peritonitis more than 2 episodes 3. History of bacterial peritonitis 3 months before randomization 4. History of fungal peritonitis

Design outcomes

Primary

Measure	Time frame
Bacterial peritonitis 1 year Criteria to diagnose bacterial peritonitis	—

Secondary

Measure	Time frame
Adverse effect from lactulose or sennoside 1 year Questions for the patient at every follow-up visit,Catheter removal 1 year Percentage of patients in each group who need to remove tenckhoff catheter	—

Countries

Thailand

Contacts

Public ContactKajohnsak Noppakun

Chiang Mai University

kajohnsak.noppakun@cmu.ac.th66-81-595-3465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026