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New treatment option for Primary Biliary Cholangitis (PBC)
Official title RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
ClinicalTrials.gov ID: NCT07161245
What this study is testing
- What it's testing
- The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary cholangitis. Consequently, this improvement is anticipated to enhance quality of life and cognitive symptoms, while also positively impacting emotional, social, and occupational aspects.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥18 years
- PBC diagnosis according to EASL guidelines
- Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire
You likely can't join if
- Age \> 80 years
- Severe pruritus
- Decompensated cirrhosis
- Other causes of liver disease than PBC
- Liver transplant (LT) o placement on a waiting-list for LT
- Uncontrolled thyroid disesase
See the full eligibility criteria
- Age ≥18 years
- PBC diagnosis according to EASL guidelines
- Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire
- Age \> 80 years
- Severe pruritus
- Decompensated cirrhosis
- Other causes of liver disease than PBC
- Liver transplant (LT) o placement on a waiting-list for LT
- Uncontrolled thyroid disesase
- Anemia with haemoglobin \<11g/dl
- Uncontrolled cardiovascular risk factors
- BMI \> 35,
- Acute myocardial infarct or unstable angina the past 6 months
- Muscle disease or systemic disease with potential muscle involvement
- Dysautonomy
- Untreated osteoporosis
- Untreated celiac disease
- Alcohol consumption \> 14 standard drinks (SD) in women and \>21 (SD) in men per week
- Chronic kidney disease ≥ 4 KDIGO stage
- Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma)
- Not capable of performing or following the prehabilitation program
- Involvement in a clinical trial the previous 2 months
- Refusal of informed consent For the study of the pathophysiology of fatigue, additional exclusion criteria will be established: Severe depression or neuropsychiatric disease, 2) Treatment with centrally acting drugs, 3)...
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.