The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP) (NCT05151913) | Clinical Trial Compass
CompletedNot Applicable
The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP)
Sweden105 participantsStarted 2017-02-14
Plain-language summary
This is an exploratory non-therapeutic study to study the microbiome patterns during pregnancy in women with ICP in order to identify specific bacterial strains for further product development.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
Arm 1
* Pregnant woman \> 18 years
* Signed informed consent for participation
* At least one previously completed parturition with ICP
* Willingness and ability to comply with the study procedures, visit schedules and other instructions regarding the study
Arm 2
* Pregnant woman ≥ 18 years (±5 calendar years from the matched subject in arm 1)
* Signed informed consent for participation
* At least one previously completed parturition
* No previous ICP
* Willingness and ability to comply with the study procedures, visit schedules and other instructions regarding the study
Exclusion Criteria:
* Multifetal pregnancy (twins, triplets etc.)
* Latin American ethnicity
* Use of any systemic antibiotics within 3 months prior to enrollment
* Medical history of liver disease (other than previous ICP for subjects in arm 1)
* Medically significant gastrointestinal disorder which, in the opinion of the investigator, may affect the results or the subject ́s ability to comply with the study
* History or concurrent status of any clinically significant disease or disorder which, in the opinion of the investigator, may influence the results or the subject ́s ability to participate in the study
* Participation in any other clinical study that included drug treatment within 3 months prior to enrollment
* Serious bacterial or chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus at enrollment visit
* Any other condition which, in the Inves…