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Compares treatment options for Autoimmune Hepatitis
Official title Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
ClinicalTrials.gov ID: NCT06250309
What this study is testing
- What it's testing
- This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.
- Which group you join is decided by chance.
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
You may be able to join if
- Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (\>6) or historical confirmatory liver biopsy with inflammation...
- Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment
- Previous enrollment in the Indiana University GRACE study
- Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55
- Diagnosis of AIH \> 6 months
You likely can't join if
- Concurrent diagnosis of celiac disease
- Concurrent use of dedicated dietary intervention (patient driven or else)
- Established diagnosis of variant syndrome (AIH with Primary biliary cholangitis, AIH with Primary sclerosing cholangitis)
- Child Pugh score \> 7
- MELDNa score \> 7
- Clinical evidence of de-compensated cirrhosis: ascites, total bilirubin \>1.5, large esophageal varices or history of bleeding, known diagnosis of...
See the full eligibility criteria
- Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (\>6) or historical confirmatory liver biopsy with inflammation consistent with AIH
- Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment
- Previous enrollment in the Indiana University GRACE study
- Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55
- Diagnosis of AIH \> 6 months
- Current age: 18 to 80 years old
- Willing and agree to comply with protocol requirements
- Female patients who are of reproductive potential must agree for the duration of the study to use an effective means of contraception (e.g., abstinence, hormonal contraception methods that inhibit ovulation...
- Capable of storing 1 week duration of frozen food and preparing meals
- Capable of receiving weekly frozen food on scheduled day of delivery
- Capable of understanding and signing the informed consent document
- Concurrent diagnosis of celiac disease
- Concurrent use of dedicated dietary intervention (patient driven or else)
- Established diagnosis of variant syndrome (AIH with Primary biliary cholangitis, AIH with Primary sclerosing cholangitis)
- Child Pugh score \> 7
- MELDNa score \> 7
- Clinical evidence of de-compensated cirrhosis: ascites, total bilirubin \>1.5, large esophageal varices or history of bleeding, known diagnosis of hepatic encephalopathy
- Women who are pregnant or breastfeeding or intend to become so for the entire duration of the study; this information will be self-reported; no pregnancy test will be performed
- History of liver transplantation
- Current treatment with an investigational drug
- Historical intolerance or allergy to foods included in a Mediterranean Diet or a Western Diet
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. 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.