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OpenTrials
Completed

NCT Number: NCT02141815

AXOS and Microbial Metabolites in CKD

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arabinoxylan-oligosaccharides

Dietary Supplement

Other names: AXOS

Maltodextrine

Dietary Supplement

Primary outcomes

  1. Serum levels of p-cresol and indole derivatives

    Time frame: After 4 weeks of intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Effect of Arabinoxylan-oligosaccharides (AXOS) on Intestinal Generation of Microbial Metabolites in Chronic Kidney Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 19, 2014
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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