Primary Biliary Cirrhosis Clinical Trial
Official title:
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Verified date | March 2017 |
Source | Pomeranian Medical University Szczecin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to
several symptoms such as intractable pruritus or chronic fatigue, significantly impairing
patients quality of life. Recent studies show, that chronic liver diseases are associated
with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for
the synthesis of SAMe from methionine. SAMe deficiency is associated with impaired
detoxification and hepatoprotection and exacerbate liver injury. Supplementation with SAMe
has proven useful in several liver diseases.
The study group will include 20 patients with PBC diagnosed with European Association for
the Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic
acid (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months.
Both clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and
urine bile acids metabolites, transient elastography and health related quality of life.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - primary biliary cirrhosis diagnosed with EASL criteria; - treatment with UDCA at least 3 months. Exclusion Criteria: - overlap syndromes (i.e. autoimmune hepatitis), viral hepatitis; - decompensated liver cirrhosis (Child-Pugh class B-C); - other diseases that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure = New York Heart Association (NYHA) II, rheumatoid arthritis, asthma, mood disorders, depression; - treatment with: steroids, statins, rifampicin, antidepressants. |
Country | Name | City | State |
---|---|---|---|
Poland | Wunsch | Szczecin | |
Poland | Milkiewicz | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Pomeranian Medical University Szczecin | Laval University |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PBC-40 questionnaire | Questionnaire consists 40 questions in 5 domains: Cognition, Itch, Fatigue, Social-Emotional and Other Symptoms, marked with a five-point scale (1=never to 5=always), with higher scores denoting greater symptoms impact and poorer quality of life. The possible range of each domain were: Other Symptoms domain 7-35, Itch 3-15, Fatigue 11-55, Cognitive 6-30, Social and Emotional 13-65 points. | 6 months | |
Secondary | Liver fibrosis measured by transient elastography | To analyse the influence of SAMe treatment on liver stiffness | 6 months | |
Secondary | Number of participants with abnormal laboratory values (liver biochemistry) | To analyse the influence of SAMe treatment on liver function parameters | 6 months | |
Secondary | Number of participants with changes in bile acids pool | To analyse the influence of SAMe treatment on 17 bile acids metabolites in serum and urine | 6 months |
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