AXOS and Microbial Metabolites in CKD

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Arabinoxylan-oligosaccharides; Dietary Supplement: Maltodextrine

• Registration Number: NCT02141815
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-19
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arabinoxylan-oligosaccharides	Arabinoxylan-oligosaccharides	Arabinoxylan-oligosaccharides 10g BID
Maltodextrine	Maltodextrine	Maltodextrine BID

Primary Outcome Measures

Name	Time	Method
Serum levels of p-cresol and indole derivatives	After 4 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Insuline resistance	After 4 weeks of intervention	Insuline resistance, measured by HOMA index
Urinary excretion rates of p-cresol and indole derivatives	After 4 weeks of intervention

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium