Aim of this prospective study is to determine (temporal changes in) the intestinal microbiota in faecal specimens and microbiota adhering to the intestinal mucosa using bacterial DNA-based profiling methods.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal inflammatory conditions
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is a bacterial profile of the intestinal microbiota derived
from the inter spacer region PCR (IS-PCR) technique.
Secondary outcome
Faecal and mucosal profiles will be compared together, and with other DNA based
techniques.
Background summary
The human gut contains over 800 bacterial species in various concentrations.
The total of bacteria in the bowel are called the intestinal microbiota. This
microbiota plays an important role in health and disease. Diseases and
disorders such as inflammatory bowel disease, irritable bowel syndrome,
colorectal cancer and obesitas seems to be linked to a certain microbiome. In
addition, the faecal microbiota fluctuates markedly in specific patient groups,
whereas this fluctuation is less clear in healthy individuals. Temporal
variation of mucosa-adherent microbiota (MAM) has hardly been studied.
The characterization of the intestinal microbiota is possible with several
DNA-based techniques including interspace region PCR profiling.
Study objective
Aim of this prospective study is to determine (temporal changes in) the
intestinal microbiota in faecal specimens and microbiota adhering to the
intestinal mucosa using bacterial DNA-based profiling methods.
Study design
A cross-sectional study will be performed. A faecal sample will be collected
before colonic cleansing. A questionnaire will be conducted. During colonoscopy
residual faecal material will be collected and additional colonic mucosa biopsy
specimens will be harvested besides usual samples for pathohistological
examination. The samples will be analysed for the intestinal microbiota using
DNA-based techniques. Stratification for patient subgroups will be applied.
Individuals undergoing subsequent colonoscopy are asked to collect additional
faecal samples. An additional mucosal biopsy is harvested during following
colonoscopy.
Study burden and risks
Participating patients are asked to collect a faecal specimen before colonic
cleansing. This specimen will be collected at home. At the day of colonoscopy a
questionnaire has to be filled in. Height and weight of the patient will be
measured.
During colonoscopy two additional biopsy specimens, besides the usual amount of
4-6 biopsy specimens, will be harvested.
In case patient is planned for addtitional colonoscopy, he/she will be asked to
collect three additional faecal samples. Two additional mucosal biopsy
specimens will be harvested during re-colonoscopy.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age 18 years and older
Informed Consent
Elective colonoscopy
Patient living within a 15km radius from the VUmc
Pre-endoscopy colonic cleansing with Kleanprep®
Exclusion criteria
Contraindication for colonoscopy
Contraindication for harvesting biopsy specimens
Other pre-endoscopy colonic cleansing than with Kleanprep®
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 | NL21085.029.07 |