To study the difference between the vaginal microbiome of fertile women with IBD and healthy controls, as determined by lactobacillus dominance.
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* vaginal microbiome
defined by the proportion and diversity of vaginal bacteria species and phyla
looking at Lactobacillus dominance, compared to fertile women without IBD, and
its associations with the intestinal microbiome.
Secondary outcome
* Is there a correlation between the vaginal microbiome composition and fecal
microbiome composition in IBD patients?
* Is the composition of the vaginal microbiome associated with patient
characteristics, e.g. diagnosis, disease activity, and vaginal symptoms?
Background summary
Inflammatory Bowel Disease (IBD) is an umbrella term for Crohn*s disease (CD)
and ulcerative colitis (UC), used to describe a chronic gastrointestinal
inflammation. IBD is often characterized by unpredictable flares between
periods of remission. Intermittent inflammation of the gastrointestinal tract
can cause abdominal pain and cramping, diarrhea, blood in the stool,
unintentional weight loss and extreme tiredness. The intestinal microbiome is
widely studied in IBD, but less is known about the vaginal microbiome. The
vaginal microbiome is a very dynamic ecosystem that consists of diverse
microorganisms, the composition of which is subject to change because of sexual
activity, menstruation and diseases like bacterial vaginosis. In healthy
reproductive-aged woman, the vaginal mucosa is predominantly populated by
Lactobaccilus spp which produce lactic acid. As a result, the low pH in the
vaginal mucosa forms a barrier for pathogenic agents from the outside world.
Recently, several studies have indicated the effect of vaginal microbiome on
the fertility and pregnancy outcomes of women in the reproductive phase. At
this moment, very little is known about the make-up of the vaginal microbiome
in IBD patients, highlighting the need for more research on this particular
topic. Therefore, our main goal is to investigate the difference in the
composition of vaginal microbiota between reproductive-aged woman with IBD and
healthy controls.
Study objective
To study the difference between the vaginal microbiome of fertile women with
IBD and healthy controls, as determined by lactobacillus dominance.
Study design
This study consists of a cross-sectional non-interventional design where a
cohort of fertile woman with IBD and healthy controls will be asked to
participate. They will be informed about the study during their routine
check-up at the Erasmus MC at the outpatient clinic.
Study burden and risks
Patients and healthy volunteers who agree to participate in the study will be
asked to provide a vaginal and fecal sample and fill out a questionnaire. 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
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
The subject signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures.
Participants are aged in the fertile phase, between 18 and 45 years.
Participants have a confirmed IBD diagnosis based on diagnostic criteria using
clinical symptoms, endoscopic, radiological and histological results.
In the opinion of the investigator, the subject is capable of understanding,
reading and speaking the Dutch language and complying with protocol
requirements.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
Postmenopausal women.
Presence of active malignancy or dysplasia.
Pregnant and/or breastfeeding women.
Presence of active rotavirus or clostridium infection at start of study.
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 | NL72730.078.20 |