Prebiotics in Peritoneal Dialysis

NCT03265639 | Completed

• 1 other identifier: 091440
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease; Gut Microbiome Dysbiosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.

  24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

• Within-patient variability in the bacterial composition of the stool during the no treatment phase.

  24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

• Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.

  24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

• Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment

  24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

• Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.

  24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

Other Outcomes (9)

• Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)

  24 weeks

• Number of Participants Who Discontinue Use of p-inulin

  8 week period of treatment

• Number of Participants Who Reduce the Dose of p-inulin

  8 week period of treatment

Study Arms (3)

Pre-treatment

NO INTERVENTION

This arm is the 8-week observation period before the p-inulin treatment phase.

Intervention

EXPERIMENTAL

This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).

Dietary Supplement: P-inulin

Post-treatment

NO INTERVENTION

This arm is the 8-week observation period after the p-inulin treatment phase.

Interventions

P-inulin DIETARY_SUPPLEMENT

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Ramezani: lead

Study Sites (2)

DaVita Georgetown Home Training Unit

Washington D.C., District of Columbia, 20007, United States

Location

DaVita K Street

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominic Raj, MD

  The George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: August 29, 2017
• Study Start: April 21, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)