To study the influence of longitudinal changes in the intestinal microbiome on fatigue, and disease course of Crohn*s disease patients.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the composition of the patients* intestinal
microbiome defined by the proportion and diversity of fecal bacteria species
and phyla, and its effect on fatigue measured by different questionnaires. This
will be measured every three months over the course of two years to account for
changes in the composition of the microbiome over time.
Secondary outcome
What is the influence of alterations in the intestinal microbiome composition
on the course of disease in patients with Crohn's disease?
Anxiety and depression
Quality of life
Disability
Blood parameters
Background summary
The composition of the intestinal microbiome is believed to be involved in the
pathogenesis of chronic diseases, including inflammatory bowel disease (IBD).
IBD patients report high rates of moderate to severe fatigue. Evidence suggests
that the intestinal microbiota act as mediator in the bidirectional
communication between nervous system and the gut. However, little is known
about the changes in the composition of the intestinal microbiome and their
influence on fatigue and the course of disease over time.
Study objective
To study the influence of longitudinal changes in the intestinal microbiome on
fatigue, and disease course of Crohn*s disease patients.
Study design
This study consists of a longitudinal prospective non-interventional design
where a cohort of IBD patients will be followed for a period of two years and
variables will be measured every three months.
Study burden and risks
Patients who agree to participate in the study will come to their habitual
check-up at the outpatient clinic of the department of Gastroenterology at
Erasmus MC every six months. As additional burden, they will be asked to
provide a fecal sample and fill out a series of questionnaires during that
visit and again three months later. This pattern will be repeated over a period
of two years. In addition, patients with an exacerbation of disease will be
asked to provide an extra fecal sample and fill out questionnaires at the time
of disease onset. The risks associated with this study are low, as no
investigational medicinal product will be used.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Aged 18 or older
Confirmed Crohn's disease based on diagnostic criteria using clinical symptoms,
endoscopic, biochemical and or histological results
Exclusion criteria
-Use of pre-, pro- and/or antibiotics within 8 weeks prior to start of the study
- Presence of active malignancy or dysplasia
- Pregnant and/or breastfeeding women
- Presence of active rotavirus or clostridium infection at start of study
- Patients with a pouch or stoma
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 | NL70469.078.19 |