Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2016-10-31
2018-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Oligofructose-enriched inulin (p-inulin)
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.
Oligofructose-enriched inulin (p-inulin)
No treatment
Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.
Interventions
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Oligofructose-enriched inulin (p-inulin)
No treatment
Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.
Eligibility Criteria
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Inclusion Criteria
2. Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2
3. Age ≥ 18 years
4. 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
5. Ability to provide informed consent
Exclusion Criteria
2. Consumption of probiotic yogurt during the past 2 weeks
3. 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.
4. Presence of HIV infection, chronic wound infection and osteomyelitis
5. Presence of or treatment for periodontal infection
6. Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
7. Cirrhosis or chronic active hepatitis
8. 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
9. Treatment with proton pump inhibitors within the last one month
10. Anticipated initiation of dialysis or kidney transplant within 9 months
11. Acute on chronic kidney disease
12. Expected survival \< 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.
13. Pregnancy, anticipated pregnancy, or breastfeeding
14. Incarceration
15. Participation in another intervention study
16. Severe anemia defined as hemoglobin \<9.0 g/dl any time during the last 3 months
17. Patients in whom frequent blood sampling may be difficult
18 Years
ALL
No
Sponsors
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George Washington University
OTHER
University of Pennsylvania
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Jennifer Gassman
Principal Investigator - Data Coordinating Center
Principal Investigators
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Kevin C. Abbott, MD, MPH
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jennifer J. Gassman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Linda F. Fried, MD, MPH
Role: STUDY_CHAIR
VA Pittsburgh Healthcare System
Locations
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The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DK099877-T
Identifier Type: -
Identifier Source: org_study_id