The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP)
NCT ID: NCT05151913
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
105 participants
OBSERVATIONAL
2017-02-14
2019-10-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The condition is associated with an increased risk of adverse fetal outcomes, including preterm labour and intrauterine death. Further, ICP is associated with an increased risk for pre-eclampsia, thyroid disease, diabetes and cancer. ICP is typically present during the third trimester, when the serum concentrations of progesterone and estrogens reach their peak, and also, the time when the gut barrier has an increased permeability. In ICP subjects, both altered progesterone and bile acid metabolism is observed.
The underlying etiology for ICP is unknown, but there are indications that the gut microbiota may be involved. It has become increasingly clear that the gut microbiota is associated with metabolic diseases and has an important function in metabolizing endogenous and dietary metabolites. Bile acids are metabolized by the gut microbiota by deconjugation and production of secondary metabolites, ursodeoxycholic acid (UDCA) being one example of a secondary bile acid produced by the microbiota. Bile acids are produced from cholesterol by a series of hepatic enzymes generating cholic acid (CA) and chenodeoxycholic acid (CDCA) in humans that are conjugated to predominantly glycine. These primary bile acids are stored in the gall bladder from where they are released upon a meal. The majority of conjugated bile acids are reabsorbed from the ileum, but through the action of microbial bile salt hydrolase (BSH), the bile acids escape reabsorption and enter the colon where they can be further metabolized. Accordingly, bile acid deconjugation reduces enterohepatic recirculation of bile acids and thereby reduces the total bile acid pool. Reduction of bile acid levels are crucial to reduce pruritus and reduce fetal complication risks in ICP.
The aim is to identify biomarkers in the microbiota associated with ICP and the onset of this disease, or state of the disease, during pregnancy. Bacterial species that have a capability for UDCA production and correlate with sulphated progesterone metabolites are of specific interest. Furthermore, bacteria with sulphating and desulphating capabilities are also of interest.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Previous ICP, recurrence
Pregnant women with at least one previously completed parturition with ICP and ICP during the present study
Exploratory
Fecal microbiome
Previous ICP, non-recurrence
Pregnant women with at least one previously completed parturition with ICP and no ICP during the present study
Exploratory
Fecal microbiome
No previous ICP
Pregnant women with at least one previously completed parturition with no previous ICP and no ICP during the present study
Exploratory
Fecal microbiome
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exploratory
Fecal microbiome
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 Investigator ́s opinion, makes the subject unsuitable for study participation
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Skane University Hospital
OTHER
Stockholm South General Hospital
OTHER
MetaboGen AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helena Strevens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Skane University Hospotal
Lund, , Sweden
Stockholm South General Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
META001
Identifier Type: -
Identifier Source: org_study_id