Prebiotics in Peritoneal Dialysis

End Stage Renal Disease Clinical Trial

Official title:

Prebiotics in Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265639
• Other study ID #: 091440
• Status: Completed
• Phase: N/A
• Start date: April 21, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• End Stage Renal Disease
• Gut Microbiome Dysbiosis
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• P-inulin

Locations

Country	Name	City	State
United States	DaVita Georgetown Home Training Unit	Washington	District of Columbia
United States	DaVita K Street	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ali Ramezani

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)	24 weeks
Other	Number of Participants Who Discontinue Use of p-inulin		8 week period of treatment
Other	Number of Participants Who Reduce the Dose of p-inulin		8 week period of treatment
Other	Number of Adverse Events		24 weeks
Other	Enrollment Refusal Rate		2 years
Other	Proportion of completed stool sample collections		24 weeks
Other	Proportion of completed blood sample collections		24 weeks
Other	Adherence rate to p-inulin	Assessed by sachet counts	8 weeks
Other	Rate of Study Withdrawal	Number of subjects who withdrew during each phase	24 weeks
Primary	Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks
Secondary	Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-patient variability in the bacterial composition of the stool during the no treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort variability in the bacterial composition during the no treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort variability in the bacterial composition during the p-inulin treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Secondary	Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)