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AXOS and Microbial Metabolites in CKD

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ClinicalTrials.gov Identifier: NCT02141815
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Arabinoxylan-oligosaccharides Dietary Supplement: Maltodextrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Arabinoxylan-oligosaccharides (AXOS) on Intestinal Generation of Microbial Metabolites in Chronic Kidney Disease
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Arabinoxylan-oligosaccharides
Arabinoxylan-oligosaccharides 10g BID
Dietary Supplement: Arabinoxylan-oligosaccharides
Other Name: AXOS

Placebo Comparator: Maltodextrine
Maltodextrine BID
Dietary Supplement: Maltodextrine



Primary Outcome Measures :
  1. Serum levels of p-cresol and indole derivatives [ Time Frame: After 4 weeks of intervention ]

Secondary Outcome Measures :
  1. Urinary excretion rates of p-cresol and indole derivatives [ Time Frame: After 4 weeks of intervention ]
  2. Insuline resistance [ Time Frame: After 4 weeks of intervention ]
    Insuline resistance, measured by HOMA index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141815


Locations
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Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Ruben Poesen, MD Universitaire Ziekenhuizen Leuven
Principal Investigator: Björn Meijers, MD, PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02141815    
Other Study ID Numbers: S55578
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency