The aim of this study is to determine the population and functionality dynamics of the microbiota in ileostomy subjects.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
From 20 ileostomy subjects the microbiota composition and functionality of
their ileostomy effluent will be determined. In addition, questions on
demographic characteristics and additional physical status (health) infomation
will be included.
Secondary outcome
none
Background summary
Our gastrointestinal (GI) tract is inhabited by large numbers of microbes which
collectively outnumber host cells by a factor of ten. The complexity of
interactions between these microbes and our intestinal cells varies
tremendously and includes pathogenic, competitive, and symbiotic interactions.
Feces is the most easily available source of gastrointestinal (GI) tract
material for microbial analysis, but since it represents the end station of the
GI tract, it is not the most suitable source of material to get insight into
the activity of GI tract microbes. Therefore, samples from ileostomy subjects
are more promising since they provide insight into the ecology of the small
intestine. The first preliminary studies with 5 healthy ileostomy subjects
indicated that the diversity and population dynamics of the microbiota are
completely distinct from those in the feces. This motivated us to study the
diversity and also functionality of the microbiota in a larger number of
ileostomy subjects.
Study objective
The aim of this study is to determine the population and functionality dynamics
of the microbiota in ileostomy subjects.
Study design
This observation study focuses on studying the diversity and functionality of
microbial communities in the GI tract of ileostomy subjects.
Study burden and risks
Ileostomy effluent samples will be collected at home by the volunteers,
sampling protocols and equipment (tubes) will be collected at home by the
volunteers, sampling protocols and equipment (tubes) will be explained to
volunteers, who will also be provided with a storage facility (polystyrene box
of dry-ice). Samples will be collected by a research team representative. There
are no risks concerning these procedures. In addition, a questionnaire
concerning demographig characteristics and physiological status (health)
information of the volunteers has to be completed.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
patients with an ileostomy, otherwise healthy, 18 years and older, able to understand the study information and to give their independent informed consent.
Exclusion criteria
recent history (i.e. last month) or current use of medication that may affect the intestinal microbiota.
use of pre- and/or probiotics during the month before the collection of the fecal samples.
pre-existing small bowel diseases (except for stoma).
pregnancy/breast feeding.
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 | NL30824.042.09 |