AXOS and Microbial Metabolites in CKD

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Arabinoxylan-oligosaccharides; Dietary Supplement: Maltodextrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02141815

S55578

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Arabinoxylan-oligosaccharides

Experimental group

Description:

Arabinoxylan-oligosaccharides 10g BID

Treatment:

Dietary Supplement: Arabinoxylan-oligosaccharides

Maltodextrine

Placebo Comparator group

Description:

Maltodextrine BID

Treatment:

Dietary Supplement: Maltodextrine