To study the diversity and functionality of intestinal microbiota of patients with IBS over time in comparison with asymptomatic controls.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome parameter is diversity and functionality of intestinal
microbiota, which will be monitored every 1-2 months during a period of 6-12
months.
Secondary outcome
Additional study parameters include quality of life, disease and treatment
characteristics, and lifestyle factors including dietary intake, clinical
patient history, family history, and demographics.
Background summary
People with irritable bowel syndrome (IBS) have functional bowel complaints
without a clear etiology, which also compromises their quality of life. The
bowel complaints in IBS often vary in time and we speculate that the alternate
course of bowel complaints in IBS may be due to alterations in the intestinal
microbiota. For this purpose, we would like to investigate the role of
microbiota in patients with IBS in a longitudinal way with special emphasis on
abdominal pain, bloating en bowel movements. We would also like to investigate
how the quality of life is associated with the composition of the microbiota.
Study objective
To study the diversity and functionality of intestinal microbiota of patients
with IBS over time in comparison with asymptomatic controls.
Study design
Prospective cohort study
Study burden and risks
Fecal samples will be collected from the volunteers, which does not pose a risk
to the volunteers. In addition, questionnaires concerning quality of life and
general lifestyle factors will be collected.
Dreijenplein 10
6703 HB Wageningen
NL
Dreijenplein 10
6703 HB Wageningen
NL
Listed location countries
Age
Inclusion criteria
* Aged 18 or older
* Subjects must be able to understand the written study information and must be able to sign an informed consent
* Subjects must be willing to collect faeces
* Specifically for IBS: Rome III Criteria
* Specifically for asymptomatic controls: no intestinal diseases in the colon
Exclusion criteria
* Change in use of medication that may affect the intestinal microbiota, such as prebiotics, and laxatives
* Recent use of probiotics (for at least one month before collection of the fecal samples)
* Pre-exiting bowel diseases (such as inflammatory bowel disease or cancer)
* 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 | NL29070.081.09 |