Intrahepatic Cholestasis of PregnancyBAPPNCT07428226
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
An observational study of Intrahepatic Cholestasis of Pregnancy, run by Jena University Hospital at 1 site in Germany.
Trial summary
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the baby. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Group 1: Participants in this group are pregnant women diagnosed with or suspected of having ICP who are being treated at the Clinic for Obstetrics, University Hospital Jena, as part of routine clinical care. Group 2: Participants in this group are healthy pregnant women without ICP who are receiving routine prenatal care at the Clinic for Obstetrics, University Hospital Jena. Group 3: Participants in this group are healthy, non-pregnant female volunteers participating in the study independently of the clinical care setting.
Who may be able to join
- Minimum age of 18 years
- Written informed consent
- Pregnant patients with suspected ICP
- Pregnant patients with confirmed ICP
- Pregnant patients with elevated total bile acids (>14 µmol/ml)
- Pregnant patients with elevated liver enzymes
Show all 16Show fewer
- Pregnant patients that suffer from itching with elevated transaminases
- Minimum age of 18 years
- Confirmed pregnancy
- Written informed consent
- Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification)
- Minimum age of 18 years
- Female gender
- Pregnancy excluded
- Written informed consent
- Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification)
Who cannot join
- Age <18 years
- Inability to provide informed consent
- Signs of an acute illness (for control groups II and III)
- Known liver, biliary, or pancreatic diseases (for control groups II and III)
- ICP in personal or family medical history (for control groups II and III)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janine Zöllkau, Dr. med. contact
Germany1 site, 1 recruiting
- Recruiting
Klinik für Geburtsmedizin, Universitätsklinikum Jena
Jena, Thuringia, 07747
Silke Große, Dr., +49 3641 9329293, silke.grosse@med.uni-jena.de
Janine Zöllkau, Dr. med., janine.zoellkau@med.uni-jena.de
About this study
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the baby. The main questions it aims to answer are:
- Can measuring specific types of bile acids (particularly taurine-conjugated versus glycine-conjugated bile acids) in the mother's and baby's blood help predict the risk of stillbirth and other complications?
- Do these bile acid patterns activate specific receptors (TGR5) that might contribute to immune problems or heart rhythm abnormalities in the baby?
- How do bile acid patterns in the mother's stool relate to her gut bacteria and the severity of ICP?
- Can heart rate monitoring (CTG) combined with bile acid measurements better identify high-risk pregnancies? ICP is a pregnancy-related liver condition that causes bile acids to build up in the mother's bloodstream. This can lead to serious risks for the baby, including an increased chance of stillbirth, premature birth, and heart rhythm problems. Current monitoring methods (such as heart rate monitoring and ultrasound) often don't show warning signs before complications occur.
Read more
Participants will:
- Provide blood samples at each routine bile acid check during pregnancy and at delivery
- Provide stool samples for analyzing gut bacteria and bile acids
- Have their baby's umbilical cord blood collected at birth for bile acid analysis
- Undergo standard heart rate monitoring (CTG) of the baby
- Have ultrasound examination of the baby's heart (echocardiography) The study will compare three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. The researchers hope this information will help doctors better predict which pregnancies need more intensive monitoring and potentially prevent stillbirths and other complications in women with ICP.
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Intrahepatic Cholestasis of pregnancy, Bile acid profile
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant ICP patients | Diagnosis or suspicion of an ICP according to Hagenbeck et al. 2021 | |
| Healthy pregnant controls | Healthy patients with a confirmed pregnancy | |
| Healthy non-pregnant controls | Healthy woman which are not pregnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
bile acid profile
Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood)
Measured: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
Secondary outcomes (3)
TGR-5 activity
TGR5 activation by immunosuppressive bile acids calculated according to published protocols (Leonhardt et al. 2021)
Measured: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
bile acid profile in stool
The bile acid profile in stool is an exploratory outcome measure that examines the composition and concentration of various bile acids in stool samples.
Measured: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
materno-fetal bile acid transfer rate (bile acid profile)
The maternal-fetal bile acid transfer rate describes the extent and efficiency with which bile acids pass from the mother through the placenta into the fetal circulation (placental permeability).
Measured: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Groten, Prof. Dr. med., Study chair, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428226
- Sponsor's protocol ID
- Reg.-Nr.: 2023-2917-Material
- Acronym
- BAPP
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: * The data concerns a vulnerable population (pregnant individuals and their newborns), which is why personal information is treated with particular sensitivity. * The local data protection policy must be observed. * In scientific cooperation, a release is conceivable after careful review and in accordance with legal, ethical, and organizational requirements.
Publications
Hagenbeck C, Hamza A, Kehl S, Maul H, Lammert F, Keitel V, Hutten MC, Pecks U. Management of Intrahepatic Cholestasis of Pregnancy: Recommendations of the Working Group on Obstetrics and Prenatal Medicine - Section on Maternal Disorders. Geburtshilfe Frauenheilkd. 2021 Aug;81(8):922-939. doi: 10.1055/a-1386-3912. Epub 2021 Aug 9.
PubMed 34393256Shao Y, Yao Z, Lu J, Li H, Wu W, Ding M. [Change of heart rate power spectrum and its association with sudden death in the fetuses of rats with intrahepatic cholestasis of pregnancy]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2007 Dec;24(6):1215-9. Chinese.
PubMed 18232463Vasavan T, Deepak S, Jayawardane IA, Lucchini M, Martin C, Geenes V, Yang J, Lovgren-Sandblom A, Seed PT, Chambers J, Stone S, Kurlak L, Dixon PH, Marschall HU, Gorelik J, Chappell L, Loughna P, Thornton J, Pipkin FB, Hayes-Gill B, Fifer WP, Williamson C. Fetal cardiac dysfunction in intrahepatic cholestasis of pregnancy is associated with elevated serum bile acid concentrations. J Hepatol. 2021 May;74(5):1087-1096. doi: 10.1016/j.jhep.2020.11.038. Epub 2020 Dec 1.
PubMed 33276032Al Inizi S, Gupta R, Gale A. Fetal tachyarrhythmia with atrial flutter in obstetric cholestasis. Int J Gynaecol Obstet. 2006 Apr;93(1):53-4. doi: 10.1016/j.ijgo.2005.12.030. Epub 2006 Mar 9. No abstract available.
PubMed 16527280Katsidzira L, Ocvirk S, Wilson A, Li J, Mahachi CB, Soni D, DeLany J, Nicholson JK, Zoetendal EG, O'Keefe SJD. Differences in Fecal Gut Microbiota, Short-Chain Fatty Acids and Bile Acids Link Colorectal Cancer Risk to Dietary Changes Associated with Urbanization Among Zimbabweans. Nutr Cancer. 2019;71(8):1313-1324. doi: 10.1080/01635581.2019.1602659. Epub 2019 Apr 22.
PubMed 31007075Li X, Xie H, Chao JJ, Jia YH, Zuo J, An YP, Bao YR, Jiang X, Ying H. Profiles and integration of the gut microbiome and fecal metabolites in severe intrahepatic cholestasis of pregnancy. BMC Microbiol. 2023 Oct 3;23(1):282. doi: 10.1186/s12866-023-02983-x.
PubMed 37784030Staley C, Weingarden AR, Khoruts A, Sadowsky MJ. Interaction of gut microbiota with bile acid metabolism and its influence on disease states. Appl Microbiol Biotechnol. 2017 Jan;101(1):47-64. doi: 10.1007/s00253-016-8006-6. Epub 2016 Nov 25.
PubMed 27888332Wahlstrom A, Sayin SI, Marschall HU, Backhed F. Intestinal Crosstalk between Bile Acids and Microbiota and Its Impact on Host Metabolism. Cell Metab. 2016 Jul 12;24(1):41-50. doi: 10.1016/j.cmet.2016.05.005. Epub 2016 Jun 16.
PubMed 27320064Lin Z, Wu J, Wang J, Levesque CL, Ma X. Dietary Lactobacillus reuteri prevent from inflammation mediated apoptosis of liver via improving intestinal microbiota and bile acid metabolism. Food Chem. 2023 Mar 15;404(Pt B):134643. doi: 10.1016/j.foodchem.2022.134643. Epub 2022 Oct 18.
PubMed 36283304Martinez-Gili L, Pechlivanis A, McDonald JAK, Begum S, Badrock J, Dyson JK, Jones R, Hirschfield G, Ryder SD, Sandford R, Rushbrook S, Thorburn D, Taylor-Robinson SD, Crossey MME, Marchesi JR, Mells G, Holmes E, Jones D. Bacterial and metabolic phenotypes associated with inadequate response to ursodeoxycholic acid treatment in primary biliary cholangitis. Gut Microbes. 2023 Jan-Dec;15(1):2208501. doi: 10.1080/19490976.2023.2208501.
PubMed 37191344Zhang X, Han S, Jiang X, Duan S, Gao Y, Ding J, Li X, Sun B, Hu X, Zhang X, Zhang W. Comparative analysis of bile metabolic profile in patients with biliary obstruction complicated by Clonorchis sinensis infection. Front Cell Infect Microbiol. 2023 Sep 12;13:1254016. doi: 10.3389/fcimb.2023.1254016. eCollection 2023.
PubMed 37868349Ryan PM, Stanton C, Caplice NM. Bile acids at the cross-roads of gut microbiome-host cardiometabolic interactions. Diabetol Metab Syndr. 2017 Dec 28;9:102. doi: 10.1186/s13098-017-0299-9. eCollection 2017.
PubMed 29299069Ridlon JM, Kang DJ, Hylemon PB, Bajaj JS. Bile acids and the gut microbiome. Curr Opin Gastroenterol. 2014 May;30(3):332-8. doi: 10.1097/MOG.0000000000000057.
PubMed 24625896Klinke P, Kurtz, Silbernagel (Hrsg.). Physiologie. In: Klinke, editor. Physiologie: Thieme; 2010. p. 471, 5.
Leonhardt J, Haider RS, Sponholz C, Leonhardt S, Drube J, Spengler K, Mihaylov D, Neugebauer S, Kiehntopf M, Lambert NA, Kortgen A, Bruns T, Tacke F, Hoffmann C, Bauer M, Heller R. Circulating Bile Acids in Liver Failure Activate TGR5 and Induce Monocyte Dysfunction. Cell Mol Gastroenterol Hepatol. 2021;12(1):25-40. doi: 10.1016/j.jcmgh.2021.01.011. Epub 2021 Feb 2.
PubMed 33545429
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT07428226
- Acronym / sponsor ID
- BAPP / Reg.-Nr.: 2023-2917-Material
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Intrahepatic Cholestasis of pregnancy, Bile acid profile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the baby. The main questions it aims to answer are:
- Can measuring specific types of bile acids (particularly taurine-conjugated versus glycine-conjugated bile acids) in the mother's and baby's blood help predict the risk of stillbirth and other complications?
- Do these bile acid patterns activate specific receptors (TGR5) that might contribute to immune problems or heart rhythm abnormalities in the baby?
- How do bile acid patterns in the mother's stool relate to her gut bacteria and the severity of ICP?
- Can heart rate monitoring (CTG) combined with bile acid measurements better identify high-risk pregnancies? ICP is a pregnancy-related liver condition that causes bile acids to build up in the mother's bloodstream. This can lead to serious risks for the baby, including an increased chance of stillbirth, premature birth, and heart rhythm problems. Current monitoring methods (such as heart rate monitoring and ultrasound) often don't show warning signs before complications occur.
Participants will:
- Provide blood samples at each routine bile acid check during pregnancy and at delivery
- Provide stool samples for analyzing gut bacteria and bile acids
- Have their baby's umbilical cord blood collected at birth for bile acid analysis
- Undergo standard heart rate monitoring (CTG) of the baby
- Have ultrasound examination of the baby's heart (echocardiography) The study will compare three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. The researchers hope this information will help doctors better predict which pregnancies need more intensive monitoring and potentially prevent stillbirths and other complications in women with ICP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant ICP patients | – | –Diagnosis or suspicion of an ICP according to Hagenbeck et al. 2021 |
| Healthy pregnant controls | – | –Healthy patients with a confirmed pregnancy |
| Healthy non-pregnant controls | – | –Healthy woman which are not pregnant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1: Participants in this group are pregnant women diagnosed with or suspected of having ICP who are being treated at the Clinic for Obstetrics, University Hospital Jena, as part of routine clinical care. Group 2: Participants in this group are healthy pregnant women without ICP who are receiving routine prenatal care at the Clinic for Obstetrics, University Hospital Jena. Group 3: Participants in this group are healthy, non-pregnant female volunteers participating in the study independently of the clinical care setting.
Key inclusion criteria (16 listed)
- Minimum age of 18 years
- Written informed consent
- Pregnant patients with suspected ICP
- Pregnant patients with confirmed ICP
- Pregnant patients with elevated total bile acids (>14 µmol/ml)
Key exclusion criteria (5 listed)
- Age <18 years
- Inability to provide informed consent
- Signs of an acute illness (for control groups II and III)
- Known liver, biliary, or pancreatic diseases (for control groups II and III)
- ICP in personal or family medical history (for control groups II and III)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bile acid profile
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood)
3 secondary outcomes
TGR-5 activity
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
bile acid profile in stool
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
materno-fetal bile acid transfer rate (bile acid profile)
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 34393256Hagenbeck C, Hamza A, Kehl S, Maul H, Lammert F, Keitel V, Hutten MC, Pecks U. Management of Intrahepatic Cholestasis of Pregnancy: Recommendations of the Working Group on Obstetrics and Prenatal Medicine - Section on Maternal Disorders. Geburtshilfe Frauenheilkd. 2021 Aug;81(8):922-939. doi: 10.1055/a-1386-3912. Epub 2021 Aug 9.
- Background: PubMed 18232463Shao Y, Yao Z, Lu J, Li H, Wu W, Ding M. [Change of heart rate power spectrum and its association with sudden death in the fetuses of rats with intrahepatic cholestasis of pregnancy]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2007 Dec;24(6):1215-9. Chinese.
- Background: PubMed 33276032Vasavan T, Deepak S, Jayawardane IA, Lucchini M, Martin C, Geenes V, Yang J, Lovgren-Sandblom A, Seed PT, Chambers J, Stone S, Kurlak L, Dixon PH, Marschall HU, Gorelik J, Chappell L, Loughna P, Thornton J, Pipkin FB, Hayes-Gill B, Fifer WP, Williamson C. Fetal cardiac dysfunction in intrahepatic cholestasis of pregnancy is associated with elevated serum bile acid concentrations. J Hepatol. 2021 May;74(5):1087-1096. doi: 10.1016/j.jhep.2020.11.038. Epub 2020 Dec 1.
- Background: PubMed 16527280Al Inizi S, Gupta R, Gale A. Fetal tachyarrhythmia with atrial flutter in obstetric cholestasis. Int J Gynaecol Obstet. 2006 Apr;93(1):53-4. doi: 10.1016/j.ijgo.2005.12.030. Epub 2006 Mar 9. No abstract available.
- Background: PubMed 31007075Katsidzira L, Ocvirk S, Wilson A, Li J, Mahachi CB, Soni D, DeLany J, Nicholson JK, Zoetendal EG, O'Keefe SJD. Differences in Fecal Gut Microbiota, Short-Chain Fatty Acids and Bile Acids Link Colorectal Cancer Risk to Dietary Changes Associated with Urbanization Among Zimbabweans. Nutr Cancer. 2019;71(8):1313-1324. doi: 10.1080/01635581.2019.1602659. Epub 2019 Apr 22.
- Background: PubMed 37784030Li X, Xie H, Chao JJ, Jia YH, Zuo J, An YP, Bao YR, Jiang X, Ying H. Profiles and integration of the gut microbiome and fecal metabolites in severe intrahepatic cholestasis of pregnancy. BMC Microbiol. 2023 Oct 3;23(1):282. doi: 10.1186/s12866-023-02983-x.
- Background: PubMed 27888332Staley C, Weingarden AR, Khoruts A, Sadowsky MJ. Interaction of gut microbiota with bile acid metabolism and its influence on disease states. Appl Microbiol Biotechnol. 2017 Jan;101(1):47-64. doi: 10.1007/s00253-016-8006-6. Epub 2016 Nov 25.
- Background: PubMed 27320064Wahlstrom A, Sayin SI, Marschall HU, Backhed F. Intestinal Crosstalk between Bile Acids and Microbiota and Its Impact on Host Metabolism. Cell Metab. 2016 Jul 12;24(1):41-50. doi: 10.1016/j.cmet.2016.05.005. Epub 2016 Jun 16.
- Background: PubMed 36283304Lin Z, Wu J, Wang J, Levesque CL, Ma X. Dietary Lactobacillus reuteri prevent from inflammation mediated apoptosis of liver via improving intestinal microbiota and bile acid metabolism. Food Chem. 2023 Mar 15;404(Pt B):134643. doi: 10.1016/j.foodchem.2022.134643. Epub 2022 Oct 18.
- Background: PubMed 37191344Martinez-Gili L, Pechlivanis A, McDonald JAK, Begum S, Badrock J, Dyson JK, Jones R, Hirschfield G, Ryder SD, Sandford R, Rushbrook S, Thorburn D, Taylor-Robinson SD, Crossey MME, Marchesi JR, Mells G, Holmes E, Jones D. Bacterial and metabolic phenotypes associated with inadequate response to ursodeoxycholic acid treatment in primary biliary cholangitis. Gut Microbes. 2023 Jan-Dec;15(1):2208501. doi: 10.1080/19490976.2023.2208501.
- Background: PubMed 37868349Zhang X, Han S, Jiang X, Duan S, Gao Y, Ding J, Li X, Sun B, Hu X, Zhang X, Zhang W. Comparative analysis of bile metabolic profile in patients with biliary obstruction complicated by Clonorchis sinensis infection. Front Cell Infect Microbiol. 2023 Sep 12;13:1254016. doi: 10.3389/fcimb.2023.1254016. eCollection 2023.
- Background: PubMed 29299069Ryan PM, Stanton C, Caplice NM. Bile acids at the cross-roads of gut microbiome-host cardiometabolic interactions. Diabetol Metab Syndr. 2017 Dec 28;9:102. doi: 10.1186/s13098-017-0299-9. eCollection 2017.
- Individual participant dataSharing planned: Undecided. * The data concerns a vulnerable population (pregnant individuals and their newborns), which is why personal information is treated with particular sensitivity. * The local data protection policy must be observed. * In scientific cooperation, a release is conceivable after careful review and in accordance with legal, ethical, and organizational requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janine Zöllkau, Dr. med. contact
Tanja Groten, Prof. Dr. med. study chair
University Hospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholestasis of Pregnancy, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silke Große, Dr. rer. nat. (+493641 9-329293, silke.grosse@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bile acid profile (time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07428226, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.