Inflammatory Bowel Disease
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| * 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? | — |
Countries
Netherlands
Outcome results
None listed