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AXOS and Microbial Metabolites in CKD

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Arabinoxylan-oligosaccharides
Maltodextrine
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and ≤ 85 years
  • Chronic kidney disease stage 3b-4, i.e., with estimated glomerular filtration rate (CKD-epi) between 45 - 15 ml/min/m² 29
  • Written informed consent

Exclusion Criteria:

  • History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy)
  • History of colonic surgery
  • Recipient of a renal or other solid organ transplant
  • Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arabinoxylan-oligosaccharides

Maltodextrine

Arm Description

Arabinoxylan-oligosaccharides 10g BID

Maltodextrine BID

Outcomes

Primary Outcome Measures

Serum levels of p-cresol and indole derivatives

Secondary Outcome Measures

Urinary excretion rates of p-cresol and indole derivatives
Insuline resistance
Insuline resistance, measured by HOMA index

Full Information

First Posted
May 15, 2014
Last Updated
April 23, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02141815
Brief Title
AXOS and Microbial Metabolites in CKD
Official Title
The Effect of Arabinoxylan-oligosaccharides (AXOS) on Intestinal Generation of Microbial Metabolites in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

5. Study Description

Brief Summary
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiota contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, overall mortality and chronic kidney disease progression. The most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in general, and AXOS more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. An interventional study with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease intestinal generation and serum concentrations of microbial metabolites in patients with CKD not yet on dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arabinoxylan-oligosaccharides
Arm Type
Experimental
Arm Description
Arabinoxylan-oligosaccharides 10g BID
Arm Title
Maltodextrine
Arm Type
Placebo Comparator
Arm Description
Maltodextrine BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Arabinoxylan-oligosaccharides
Other Intervention Name(s)
AXOS
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrine
Primary Outcome Measure Information:
Title
Serum levels of p-cresol and indole derivatives
Time Frame
After 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Urinary excretion rates of p-cresol and indole derivatives
Time Frame
After 4 weeks of intervention
Title
Insuline resistance
Description
Insuline resistance, measured by HOMA index
Time Frame
After 4 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 85 years Chronic kidney disease stage 3b-4, i.e., with estimated glomerular filtration rate (CKD-epi) between 45 - 15 ml/min/m² 29 Written informed consent Exclusion Criteria: History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy) History of colonic surgery Recipient of a renal or other solid organ transplant Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Poesen, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Björn Meijers, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
27100399
Citation
Poesen R, Evenepoel P, de Loor H, Delcour JA, Courtin CM, Kuypers D, Augustijns P, Verbeke K, Meijers B. The Influence of Prebiotic Arabinoxylan Oligosaccharides on Microbiota Derived Uremic Retention Solutes in Patients with Chronic Kidney Disease: A Randomized Controlled Trial. PLoS One. 2016 Apr 21;11(4):e0153893. doi: 10.1371/journal.pone.0153893. eCollection 2016.
Results Reference
derived

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AXOS and Microbial Metabolites in CKD

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