Status:
COMPLETED
Prebiotics in Peritoneal Dialysis
Lead Sponsor:
Ali Ramezani
Conditions:
End Stage Renal Disease
Gut Microbiome Dysbiosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.
Eligibility Criteria
Inclusion
- Peritoneal dialysis therapy for end-stage renal disease
- ≥30 days since dialysis initiation
- Ability to provide informed consent
Exclusion
- Use of pre- or pro-biotics during the past 2 months
- Consumption of pro-biotic yogurt during the past 2 weeks
- Use of antibiotics within the past 2 months
- Presence of chronic infection
- Chronic gastrointestinal condition other than constipation
- Cirrhosis or chronic active hepatitis
- Stomach/intestinal resection
- PD access problems
- Anticipated kidney transplant or transfer to another dialysis unit within 9 months
- Expected survival \< 9 months
- Pregnancy, anticipated pregnancy, or breastfeeding
- Incarceration
- Participation in another intervention study
- Severe anemia defined as hemoglobin \<9.0 g/dl
Key Trial Info
Start Date :
April 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03265639
Start Date
April 21 2016
End Date
February 28 2018
Last Update
November 19 2018
Active Locations (2)
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1
DaVita Georgetown Home Training Unit
Washington D.C., District of Columbia, United States, 20007
2
DaVita K Street
Washington D.C., District of Columbia, United States, 20037