The vaginal microbiome of fertile inflammatory bowel disease women, a comparison study
- Conditions
- Inflammatory Bowel Disease10017969
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 83
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the composition of the patients* vaginal microbiome<br /><br>defined by the proportion and diversity of vaginal bacteria species and phyla<br /><br>looking at Lactobacillus dominance, compared to fertile women without IBD, and<br /><br>its associations with the intestinal microbiome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Is there a correlation between the vaginal microbiome composition and fecal<br /><br>microbiome composition in IBD patients?<br /><br>* Is the composition of the vaginal microbiome associated with patient<br /><br>characteristics, e.g. diagnosis, disease activity, and vaginal symptoms? </p><br>