NCT05151913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

October 25, 2021

Last Update Submit

November 26, 2021

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

PregnancyMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Gut microbiome composition

    Change in gut microbiome composition

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

Secondary Outcomes (5)

  • Bile acids levels

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

  • Liver function test AST

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

  • Liver function test ALT

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

  • Liver function test GGT

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

  • Liver function test bilirubin

    Pregnancy week 9+0 - 19+6 until 6 weeks post-partum (+ 2 weeks)

Study Arms (3)

Previous ICP, recurrence

Pregnant women with at least one previously completed parturition with ICP and ICP during the present study

Other: Exploratory

Previous ICP, non-recurrence

Pregnant women with at least one previously completed parturition with ICP and no ICP during the present study

Other: Exploratory

No previous ICP

Pregnant women with at least one previously completed parturition with no previous ICP and no ICP during the present study

Other: Exploratory

Interventions

ExploratoryOTHER

Fecal microbiome

No previous ICPPrevious ICP, non-recurrencePrevious ICP, recurrence

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women with previous ICP and matched controls
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with previously completed parturition with intrahepatic cholestasis of pregnancy and matched controls

You may qualify if:

  • 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

You may not qualify if:

  • 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 Investigator ́s opinion, makes the subject unsuitable for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skane University Hospotal

Lund, 22185, Sweden

Location

Stockholm South General Hospital

Stockholm, 11883, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples are collected for analyzing the gut microbiome

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Study Officials

  • Helena Strevens, MD, PhD

    Skane University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

December 9, 2021

Study Start

February 14, 2017

Primary Completion

October 14, 2019

Study Completion

October 14, 2019

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

SE(2)