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Gut Microbiome and p-Inulin in CKD - TarGut CKD Study

NCT03348592 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-11-21

No results posted yet for this study

Summary

The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.

Conditions

  • Chronic Kidney Diseases

Interventions

DIETARY_SUPPLEMENT

Oligofructose-enriched inulin (p-inulin)

OTHER

No treatment

Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Kevin C. Abbott, MD, MPH · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Jennifer J. Gassman, Ph.D. · The Cleveland Clinic

  • Linda F. Fried, MD, MPH · VA Pittsburgh Healthcare System

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-11-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348592 on ClinicalTrials.gov