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

NCT03348592 | Unknown DMC

• 1 other identifier: DK099877-T
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Chronic Kidney Diseases

Keywords

Microbiome, p-inulin

Outcome Measures

Primary Outcomes (2)

• Microbial composition of stool

  Microbial taxonomy will be assigned using Ribosomal Database Project (RDP) for 16S, augmented by analysis of specific sequences using BLAST. The 16S tag sequences will be collected into operational taxonomic units (OTUs) with 97% sequence identity.

  Stool is collected weekly for 28 weeks

• Adherence to p inulin prescription

  Proportion of packets taken vs packets prescribed by packet count

  Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin

Secondary Outcomes (21)

• butyrate

  Collected weekly for 28 weeks

• propionate

  Collected weekly for 28 weeks

• acetate

  Collected weekly for 28 weeks

• Trimethylamine N oxide

  Collected weekly for 28 weeks

• Choline

  Collected weekly for 28 weeks

Study Arms (1)

Oligofructose-enriched inulin (p-inulin)

EXPERIMENTAL

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.

Dietary Supplement: Oligofructose-enriched inulin (p-inulin); Other: No treatment

Interventions

Oligofructose-enriched inulin (p-inulin) DIETARY_SUPPLEMENT

Oligofructose-enriched inulin (p-inulin)

No treatment OTHER

Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.

Oligofructose-enriched inulin (p-inulin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of pre- or pro-biotics during the past 2 months
• Consumption of probiotic yogurt during the past 2 weeks
• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• George Washington University: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin C. Abbott, MD, MPH

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

• Jennifer J. Gassman, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Linda F. Fried, MD, MPH

  VA Pittsburgh Healthcare System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Data Coordinating Center

Model Details: This is a 28 week study. Participants take no treatment for 8 weeks, followed by 12 weeks on the pre-biotic p-inulin, followed by no treatment for 8 weeks. The treatment arms are no treatment and the pre-biotic p-inulin. Inulin is derived from chicory root fiber.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 21, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: June 1, 2018
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

US (1)