Investigate whether restoration of intestinal butyratelevels improves the intestinal barrier function and decreases the inflammatory status in CKD patients.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Among patients with chronic kidney disease (CKD) and renal failure the
morbidity and mortality rate is, despite renal replacement therapy, still very
high. An important factor is the ongoing chronic systemic inflammation in these
patients which is associated with a variety of conditions such as
cardiovascular complications, fatigue and depression.
The exact aetiology behind this chronic systemic inflammation is not yet
clarified and in the recent years the observed intestinal alterations in CKD
have been pointed out as a possible source. An increased intestinal
permeability due to a decreased barrier function is causing bacterial
translocation into the blood stream [3], which could be one of the triggers of
the inflammatory response.
Butyrate is found in food products such as butter, cheese and milk. Furthermore
it is produced through saccharoloytic fermentation of carbohydrates that escape
digestion and absorption in the small intestine. Butyrate is an important
energy source for intestinal epithelial cells and is known to promote cell
differentiation and supress colonic inflammation. Restoration of intestinal
butyrate levels could possible restore intestinal epithelial cells and thus
barrier function, leading to a decrease in bacterial translocation and a
decreased inflammatory response. A decrease in systemic inflammatory response
could potentially lead to a decreased morbidity and mortality in patients with
renal disease. First of all considering cardiovascular events but possibly also
with regard to complaints such as fatigue and depression.
Study objective
Investigate whether restoration of intestinal butyratelevels improves the
intestinal barrier function and decreases the inflammatory status in CKD
patients.
Study design
Non-randomized clinical trial.
Intervention
Oral administration of 4 grams sodium butyrate a day for one month.
Study burden and risks
Oral butyrate has been given before to human subjects in identical dosages
without adverse effects. In previous trials conducted in the AMC (MEC 13/239
and MEC 2014_291) no side effects were reported. For the dialysis patients
blood samples will be collected prior dialysis and will thus not cause an
additional risk or burden for the patients. For the post-NTX group the venous
puncture will cause a small additional burden.
It is not yet clear whether patients will experience beneficial effects from
the treatment.
Meibergdreef 9 Kamer F4-110
Amsterdam 1105 AZ
NL
Meibergdreef 9 Kamer F4-110
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58389.018.16 |