Intestinale inflammatie in patienten met een ileostoma of transversostoma - een pilot studie

Rationale: To investigate the effect of nutritional interventions upon
intestinal inflammation, a human model with low grade intestinal inflammation
is necessary. In the past, patients with ulcerative colitis in remission have
been subject of study, but the disadvantage of this model is that there may be
genetic differences which cause inflammation in these patients which can
confound the results. Patients with a stoma on their transverse colon to
protect the anastomosis after partial colonic resection suffer from diversion
colitis, which is intestinal inflammation that attenuates after bowel
continuity is restored. Since these patients have a normal colon mucosa before
the stoma is constructed, are generally in a good condition and and do not
suffer from clinical relevant symptoms, this model can be ultimately suitable
to investigate the effect of nutritional interventions. Similar to the
development of abnormalities in the large intestine in patients with a
transverse stoma, abnormalities are also observed in the bypassed part of the
small intestine in patients with an ileostomy. Most likely, lack of bile in the
bypassed small intestine is responsible for these abnormalities. Recently, bile
acids have shown to be natural ligands for the farnesoid X receptor (FXR), a
ligand-activated nuclear receptor transcription factor predominantly residing
the epithelium of the ileum. In animal studies it has been shown that
FXR-agonists protect against intestinal bacterial overgrowth and maintain
intestinal integrity. To the best of our knowledge, human studies exploring the
role of the FXR are lacking. When the FXR has proven to be involved in bile
acid binding, it may be appealing to supply specific FXR agonists that are
currently available in order to restore gut health.

Objective: The aim of this pilot study is to investigate the degree and
stability of intestinal inflammation in patients with a stoma on the ileum.
Secondly, we want to validate a technique using filter papers to quantify
intestinal inflammation in these patients.

Study design: an observational design.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
The patients included in this pilot study are not minors or incapacitated
persons.
After informed consent is obtained, the patients will be asked to fill out a
general questionnaire about medical history and diet preferences. This will
take approximately 20 minutes.
The expected burden for the patient related to the endoscopic procedure is as
follows: the first planned endoscopy is part of regular care, during this
procedure patency of the anastomosis is checked. The second endoscopy is not
regular care, but will be done just before the stoma will be closed in the
operating room. The patient will be under general anesthesia, just before the
operation is started a second endoscopy will be performed. In this way the
discomfort for the patient is minimized. An endoscopy takes about 20 minutes.
During endoscopy we will use filter papers to absorb mucosal exudates; no risks
are associated with this method. Three biopsies will be taken during endoscopy
in the afferent loop as well as in the efferent loop of the stoma (in total 6
biopsies). The risk of taking biopsies during endoscopy is bowel perforation.
The risk of bowel perforation and bleeding is very low, (0.08%) at the biopsy
sites 2. However, this risk is expected to be much smaller in the present
study, because no severely ill subjects will be recruited. Complications mainly
appear after removal of polyps. A report of the *gezondheidsraad* mentions a
risk of 0.0025% risk of perforation after screening for cancer in healthy
subjects, which will be similar in patients with an ileostomy.