Skip to content

AXOS and Microbial Metabolites in CKD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02141815
Enrollment
40
Registered
2014-05-19
Start date
2014-05-31
Completion date
2016-05-31
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

DIETARY_SUPPLEMENTArabinoxylan-oligosaccharides
DIETARY_SUPPLEMENTMaltodextrine

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum levels of p-cresol and indole derivativesAfter 4 weeks of intervention

Secondary

MeasureTime frameDescription
Urinary excretion rates of p-cresol and indole derivativesAfter 4 weeks of intervention
Insuline resistanceAfter 4 weeks of interventionInsuline resistance, measured by HOMA index

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026