NCT03348592

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

Gut Microbiome and p-Inulin in CKD TarGut CKD Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in CKD patients. In order to design a future clinical trial the following parameters from CKD subjects are needed: 1. Intra-patient variability in the composition and function of the gut microbiome 2. Inter-patient variability in the composition and function of the gut microbiome 3. Impact of p-inulin on the composition and function of the gut microbiome 4. Tolerability of p-inulin administration 5. Feasibility of collecting stool samples in this patient population

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-11-01
• Completion: 2018-06-01
• First posted: 2017-11-21
• Last updated: 2017-11-21

Locations

1 site across 1 country: United States