Probiotic Human Study Design and Reporting (PRODARE): Recommendations to Improve Research Practice.

Area of Science:

• Microbiology and Clinical Research
• Human Microbiome Studies
• Nutritional Science

Background:

• Designing human studies with probiotics presents unique challenges, particularly concerning product viability and strain specificity.
• Existing research guidelines often lack the specificity required for live, strain-specific microorganisms.
• Methodological inconsistencies can hinder the interpretation and reproducibility of probiotic research.

Purpose of the Study:

• To introduce the PRODARE recommendations, a consensus-based framework for designing and reporting human studies involving probiotics.
• To provide a structured decision tree to guide researchers in selecting appropriate study designs based on their objectives.
• To enhance the quality, rigor, and reporting standards of probiotic research.

Main Methods:

• Identification and description of five key study types: exploratory, pilot, randomized controlled trials (RCTs), real-world studies, and observational cohort studies.
• Emphasis on probiotic-specific considerations including strain characterization, viability, purity, and dosage consistency.
• Development of a structured decision-making process linking study objectives to design and reporting standards.

Main Results:

• The PRODARE framework categorizes studies into five distinct types, each with specific design and reporting requirements.
• Key probiotic-specific factors such as strain identity, viability, and purity are highlighted as critical for all study types.
• A decision tree is presented to assist researchers in choosing the most appropriate study design.

Conclusions:

• The PRODARE recommendations provide a comprehensive, tailored framework to address the complexities of human probiotic research.
• Adherence to these guidelines will improve the quality, consistency, and interpretability of findings from probiotic intervention studies.
• This framework aims to standardize the design and reporting of probiotic studies, ultimately advancing the field.