Disorder of bile acid synthesis

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ORPHA:79168
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2Active trials3Specialists8Treatment centers

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Overview

Disorders of bile acid synthesis are a group of rare inherited conditions where the body cannot properly make bile acids. Bile acids are special chemicals produced in the liver that help digest fats and fat-soluble vitamins (like vitamins A, D, E, and K) from the food you eat. They also help keep the liver healthy by allowing waste products to flow out of it. When bile acid synthesis is disrupted, harmful substances can build up in the liver, and the body cannot absorb important nutrients properly. These disorders are sometimes called 'inborn errors of bile acid metabolism' or 'primary bile acid synthesis defects.' There are several different types, each caused by a problem in a different gene that controls a step in the bile acid production process. The most common symptoms include yellowing of the skin and eyes (jaundice), liver disease, poor growth, and signs of vitamin deficiency such as weak bones or vision problems. The good news is that some forms of this condition can be treated effectively with oral bile acid replacement therapy. Cholic acid (sold as Kolbam) is an FDA-approved treatment that can significantly improve liver function and quality of life for many patients, especially when started early. Without treatment, the disease can progress to serious liver damage, but with proper care, many patients do well.

Key symptoms:

Yellowing of the skin and whites of the eyes (jaundice)Enlarged liver or spleenPoor weight gain and slow growth in infants and childrenPale or greasy stoolsDark urineItchy skinFatigue and low energyEasy bruising or bleeding (due to vitamin K deficiency)Bone pain or fractures (due to vitamin D deficiency)Vision problems, especially night blindness (due to vitamin A deficiency)Nerve problems such as numbness or balance difficulties (due to vitamin E deficiency)Abdominal pain or swellingLiver scarring (cirrhosis) in advanced cases

Inheritance

Autosomal recessive

Passed on when both parents carry the same gene change; often skips generations

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗NORD ↗

FDA & Trial Timeline

2 events
Mar 2024Bile Acids As Determinants of Postprandial Metabolism

University of Sao Paulo — NA

TrialACTIVE NOT RECRUITING
Jul 2017The REPLACE Registry for Cholbam® (Cholic Acid)

Mirum Pharmaceuticals, Inc.

TrialACTIVE NOT RECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Disorder of bile acid synthesis.

2 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

2 recruitingView all trials with filters →
N/A1 trial
Bile Acids As Determinants of Postprandial Metabolism
N/A
Active
· Sites: São Paulo, São Paulo · Age: 1870 yrs
Other1 trial
The REPLACE Registry for Cholbam® (Cholic Acid)
Active
PI: Sagar A Vaidya, MD, PhD (Vice President, Clinical Development) · Sites: Birmingham, Alabama; Palo Alto, California +21 more

Specialists

3 foundView all specialists →
SP
Sagar A Vaidya, MD, PhD
BOSTON, MA
Specialist
PI on 1 active trial
JM
James E Heubi, MD
Specialist
PI on 1 active trial
AP
Adele Costabile, PhD
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Disorder of bile acid synthesis.

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Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

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Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.Which specific type of bile acid synthesis disorder does my child (or I) have, and which gene is affected?,Is my child a candidate for cholic acid (Kolbam) treatment, and how soon should we start?,How much liver damage has already occurred, and is it reversible with treatment?,What vitamins should be supplemented, and at what doses?,How often do we need blood tests and specialist visits to monitor the condition?,Are other family members at risk, and should they be tested?,What signs should prompt me to seek emergency care?

Common questions about Disorder of bile acid synthesis

What is Disorder of bile acid synthesis?

Disorders of bile acid synthesis are a group of rare inherited conditions where the body cannot properly make bile acids. Bile acids are special chemicals produced in the liver that help digest fats and fat-soluble vitamins (like vitamins A, D, E, and K) from the food you eat. They also help keep the liver healthy by allowing waste products to flow out of it. When bile acid synthesis is disrupted, harmful substances can build up in the liver, and the body cannot absorb important nutrients properly. These disorders are sometimes called 'inborn errors of bile acid metabolism' or 'primary bile a

How is Disorder of bile acid synthesis inherited?

Disorder of bile acid synthesis follows a autosomal recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

Are there clinical trials for Disorder of bile acid synthesis?

Yes — 2 recruiting clinical trials are currently listed for Disorder of bile acid synthesis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Disorder of bile acid synthesis?

3 specialists and care centers treating Disorder of bile acid synthesis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.