Effects of bowel lavage on engraftment in irratble bowel patients treated with fecal microbiota transplantation

There is growing interest in the human gut microbiota and its involvement in
several gastro-intestinal (GI) disorders and extra intestinal disorders. IBS is
on the most common of these disorders affecting between 10-15% of adults in
developed countries. There is growing evidence that gut microbiota is involved
in the pathogenesis and or the pathophysiology of IBS.

Fecal microbiota transplantation (FMT) is a safe and efficacious treatment for
an altered microbiota. The level of engraftment of donor microbiota to the
recipient is probably associated with a better treatment outcome. Patients
treated with FMT for recurring Clostridium difficile infections receive a bowel
lavage prior to treatment. The rationale behind the bowel lavage is that it
washes out the C. difficile spores and leads to better engraftment of donor
microbiota, however there is little to no evidence that supports this.

Our hypothesis is that treatment with FMT without bowel lavage leads to a
similar level of engraftment compared to patients who receive bowel lavage one
day prior to FMT.

Primary objective: to evaluate if bowel lavage prior to donor fecal infusion
leads to better engraftment of the donor microbiota
Secondary objective: to follow structural changes in microbiota profile post-FMT
Secondary objective: to assess the effects of FMT on IBS symptoms

Randomized controlled, single center, open label trial

IBS patients will be treated with FMT to assess the difference in engraftment
in patients pre-treated with bowel lavage (conventional arm) compared to
patients not pre-treated with bowel lavage (experimental) .
Bowel lavage will be performed by administration of 1 liter Moviprep ® or 2
liters KleanPrep® the day prior to FMT.

Colon lavage and insertion of a duodenal tube could cause inconveniency. A
recent meta-analysis showed that FMT can lead to serious adverse events,
however a closer look into these cases showed that these events should be
attributed to the route of administration and not the FMT itself. Main side
effects of donor feces infusion can be diarrhea, cramping, belching, nausea,
abdominal pain, and dizziness, which resolve within a few days. Participating
patients are asked to collect fecal samples, and fill out a an IBS
questionnaire before and after FMT. Patients will have brief scheduled
telephone contacts at 1 week, 1 month, 3 months, and 6 months after FMT to
discuss recovery and presence of recurrence or adverse events. When the fecal
samples from the NDFB are delivered at the VUmc, the samples will be stored at
-80°C at the department of Medical Microbiology and Infection Prevention until
further handling.