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Prebiotic
Gut Microbiome and p-Inulin in CKD - TarGut CKD Study (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
No Placebo-Only Group
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
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to p inulin prescription
Microbial composition of stool
Secondary study objectives
Allantoin
Betaine
Choline
+18 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,456 Previous Clinical Trials
4,335,113 Total Patients Enrolled
George Washington UniversityOTHER
254 Previous Clinical Trials
466,577 Total Patients Enrolled
University of PennsylvaniaOTHER
2,082 Previous Clinical Trials
42,726,694 Total Patients Enrolled
Jennifer J. Gassman, Ph.D.Principal InvestigatorThe Cleveland Clinic
Kevin C. Abbott, MD, MPHStudy DirectorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Linda F. Fried, MD, MPHStudy ChairVA Pittsburgh Healthcare System