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*Effects of Butyrate on Intestinal permeability & inflammation, Intellectual performance, Immune activation and systemic Inflammation in renal disease.

*Effects of Butyrate on Intestinal permeability & inflammation, Intellectual performance, Immune activation and systemic Inflammation in renal disease. - B4I-study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43237
Enrollment
30
Registered
2016-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

chronic kidney disease Renal failure

Interventions

Oral administration of 4 grams sodium butyrate a day for one month.
Intestinal permeability
Kidney disease
Systemic inflammation

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For the haemodialysis group: - Haemodialysis patients, stable on dialysis for >6 months ;For the post renal transplantation group: - Functional renal allograft, 6-24 months post transplantation;Furthermore: age 40-70, non-smoking, BMI between 20 and 30.

Exclusion criteria

Exclusion criteria: - Diabetics - Antibiotic treatment within the last 3 months - Probiotic use - Chronic diarrhoea or fulfilling the criteria for irritable bowel syndrome - Irritable bowel disorder or other comorbidity that might affect the intestinal flora - Dysphagia - Active infection (CMV, EBV)

Design outcomes

Primary

MeasureTime frame
The main study parameters consist of markers of: - Intestinal permeability: quantitative amount of bacterial DNA in blood, d-lactate, IFAP, indoxyl sulfate - Inflammation: CPR, IL-6, macrophage and monocyte activation.

Secondary

MeasureTime frame
Other parameters include: - Serum and faecal butyrate levels - Lipid spectrum - Changes in gut microbiome - Eating habits evaluated by diet lists - Questionairs evaluating meantal performance and quality of life (RAND-36, HADS) and fatigue (Checklist Individuele Spankracht)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)