Status:
UNKNOWN
Gut Microbiome and p-Inulin in CKD - TarGut CKD Study
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
George Washington University
University of Pennsylvania
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-i...
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 microb...
Eligibility Criteria
Inclusion
- Subjects with eGFR 15.0 to 50.0 ml/min/1.73 m2 as estimated by the CKD-EPI equation
- Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2
- Age ≥ 18 years
- For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. See Section 4.2.1 for definition of childbearing potential and acceptable methods of birth control
- Ability to provide informed consent
Exclusion
- Use of pre- or pro-biotics during the past 2 months
- Consumption of probiotic yogurt during the past 2 weeks
- Use of antibiotics within the past 3 months if the patient received a single course of antibiotic. If the patient received more than one course of antibiotic treatment, we will wait for 6 months prior to inclusion.
- Presence of HIV infection, chronic wound infection and osteomyelitis
- Presence of or treatment for periodontal infection
- Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
- Cirrhosis or chronic active hepatitis
- Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \>10 mg in the last 3 months
- Treatment with proton pump inhibitors within the last one month
- Anticipated initiation of dialysis or kidney transplant within 9 months
- Acute on chronic kidney disease
- Expected survival \< 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.
- Pregnancy, anticipated pregnancy, or breastfeeding
- Incarceration
- Participation in another intervention study
- Severe anemia defined as hemoglobin \<9.0 g/dl any time during the last 3 months
- Patients in whom frequent blood sampling may be difficult
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03348592
Start Date
October 1 2016
End Date
June 1 2018
Last Update
November 21 2017
Active Locations (1)
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1
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037