Clinical trial NCT03265639: Prebiotics in Peritoneal Dialysis
Official title: Prebiotics in Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Gut Microbiome Dysbiosis
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Criteria:

* Peritoneal dialysis therapy for end-stage renal disease
* ≥30 days since dialysis initiation
* Ability to provide informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
timeFrame: 24 weeks
Secondary outcomes:
measure: Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-patient variability in the bacterial composition of the stool during the no treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort variability in the bacterial composition during the no treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort variability in the bacterial composition during the p-inulin treatment phase.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
measure: Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.
timeFrame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Other outcomes:
measure: Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 24 weeks
measure: Number of Participants Who Discontinue Use of p-inulin
timeFrame: 8 week period of treatment
measure: Number of Participants Who Reduce the Dose of p-inulin
timeFrame: 8 week period of treatment
measure: Number of Adverse Events
timeFrame: 24 weeks
measure: Enrollment Refusal Rate
timeFrame: 2 years
measure: Proportion of completed stool sample collections
timeFrame: 24 weeks
measure: Proportion of completed blood sample collections
timeFrame: 24 weeks
measure: Adherence rate to p-inulin
timeFrame: 8 weeks
measure: Rate of Study Withdrawal
timeFrame: 24 weeks
Locations:
city: Washington
country: United States
facility: DaVita Georgetown Home Training Unit
state: District of Columbia
city: Washington
country: United States
facility: DaVita K Street
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Dominic Raj, MD
role: PRINCIPAL_INVESTIGATOR
References: