Indianapolis, INNCT06250309Now EnrollingIRB Ready

Autoimmune Hepatitis Clinical Trial in Indianapolis, IN

Access cutting-edge autoimmune hepatitis treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Indiana University

Quick Self-Assessment

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Expert Care in Indianapolis

Access autoimmune hepatitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related autoimmune hepatitis treatment provided free

Apply for This Indianapolis Location

Check if you qualify for this autoimmune hepatitis clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Autoimmune Hepatitis Study in Indianapolis

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.

Sponsor: Indiana University

Who Can Participate

Inclusion 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, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner)
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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT06250309) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autoimmune Hepatitis Treatment Options in Indianapolis, IN

If you're searching for autoimmune hepatitis treatment options in Indianapolis, IN, this clinical trial (NCT06250309) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced autoimmune hepatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autoimmune hepatitis clinical trials near you to find additional studies recruiting in your area.

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