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Developing new celiac disease (CeD) treatments requires standardized clinical trial designs. This study provides consensus recommendations for CeD randomized controlled trials (RCTs), focusing on eligibility and outcome measures.

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Area of Science:

  • Gastroenterology
  • Clinical Trial Design
  • Celiac Disease Research

Background:

  • Safe and effective pharmacologic treatments for celiac disease (CeD) are needed.
  • A lack of consensus exists regarding the optimal design of randomized controlled trials (RCTs) for CeD.
  • Standardized approaches are crucial for advancing CeD therapeutic development.

Purpose of the Study:

  • To establish consensus on the appropriate design and configuration of RCTs for celiac disease.
  • To provide standardized recommendations for key aspects of CeD clinical trials.
  • To guide future research in pharmacologic treatments for CeD.

Main Methods:

  • A 2-round modified Research and Development/University of California Los Angeles Appropriateness Method study was employed.
  • Eighteen expert gastroenterologists and gastrointestinal pathologists voted on statements regarding CeD RCTs.
  • Two distinct RCT designs were evaluated: those incorporating a gluten challenge and those assessing reversal of histologic changes.

Main Results:

  • Recommendations were established for participant eligibility criteria, including dietary adherence and baseline histology.
  • Specific guidance was provided for conducting gluten challenges (e.g., FODMAPs-free) and selecting outcome measures.
  • Both histologic and patient-reported outcomes were considered appropriate for evaluating treatment efficacy in CeD trials.

Conclusions:

  • Standardized recommendations for CeD clinical trial design, eligibility, and outcome measures have been developed.
  • These recommendations aim to improve the consistency and rigor of future RCTs in celiac disease.
  • The consensus provides a framework for evaluating novel pharmacologic interventions for CeD.