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Can exercise, diet, and counseling beat fatigue in PBC?

NCT ID NCT07161245

Symptom relief Sponsor: Hospital Clinic of Barcelona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a program combining exercise, nutritional advice, and psychological support can reduce fatigue in people with primary biliary cholangitis (PBC). 64 participants with moderate to severe fatigue will be randomly assigned to either the rehab program or standard care. The goal is to see if this non-drug approach improves fatigue, quality of life, and cognitive symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
multimodal rehabilitation program (exercise, nutritional counseling, psychological support)
What this could lead to
If it works, this could offer a non-drug way to reduce fatigue and improve quality of life for people with primary biliary cholangitis.
What could go wrong
This is a small, early-phase trial with only 64 participants. The program requires significant commitment, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * PBC diagnosis according to EASL guidelines * Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire Exclusion Criteria: * 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) Muscular or systemic disease with potential muscle involvement, 4) Immunosuppressive treatment, 5) Sleep disorder, 6) Obesity (BMI \>30).

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Conditions

The condition(s) this trial relates to.

Fatigue Motor Activity primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis (PBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.