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Prebiotic
Oligofructose-enriched inulin (p-inulin) for Chronic Kidney Disease (TarGut Trial)
N/A
Waitlist Available
Led By Jennifer J. Gassman, Ph.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected weekly for 28 weeks
Awards & highlights
TarGut Trial 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.
Eligible Conditions
- Chronic Kidney Disease
TarGut Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected weekly for 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected weekly for 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to p inulin prescription
Microbial composition of stool
Secondary outcome measures
Allantoin
Betaine
Choline
+18 moreTarGut Trial Design
1Treatment groups
Experimental Treatment
Group I: Oligofructose-enriched inulin (p-inulin)Experimental Treatment2 Interventions
Participants are on no treatment for 8 weeks, then the pre-biotic p-inulin for 12 weeks, then no treatment for 8 weeks. Inulin is derived from chicory root fiber. The dose is 16 grams of p-inulin powder per day.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,315,477 Total Patients Enrolled
George Washington UniversityOTHER
243 Previous Clinical Trials
453,756 Total Patients Enrolled
University of PennsylvaniaOTHER
2,004 Previous Clinical Trials
42,882,131 Total Patients Enrolled
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