Early oral anti-inflammatory diet in patients with mild acute pancreatitis: study protocol for a randomized controlled trial.

The trial uses a randomized controlled design with 72 patients with mild acute pancreatitis assigned equally to intervention and control groups.

• 72 patients total were enrolled, with 36 patients randomly assigned to each group.
• Mild acute pancreatitis was diagnosed using the revised Atlanta criteria.
• The study is a single-center randomized controlled trial.
• The trial is registered at the Chinese Clinical Trial Registry under number ChiCTR2400094056.

The intervention group received an early oral anti-inflammatory diet protocol with two defining features.

• Oral intake was initiated within 48 hours of enrollment.
• Daily food intake followed a diet with a Dietary Inflammatory Index (DII) score of less than 0, as formulated by the research group.
• The DII score threshold of less than 0 was used to operationalize an anti-inflammatory dietary pattern.

The control group received conventional nutritional management following standard clinical practice.

• Oral intake initiation was directed by the treating physician.
• Dietary advancement followed a stepwise protocol: 'clear liquid to full liquid to low-fat soft diet.'
• This represents the comparator arm against which the anti-inflammatory diet intervention is evaluated.

Primary outcomes encompass inflammatory biomarkers, nutritional indicators, and gut microbiota composition.

• Inflammatory biomarkers were designated as primary outcomes.
• Nutritional indicators were included as primary outcomes.
• Gut microbiota analysis was planned using 16S rRNA sequencing.
• The rationale is that the anti-inflammatory diet exerts effects by suppressing inflammatory mediators and modulating gut microbiota to reduce inflammation.

Secondary outcomes included average hospital stay duration and hospital costs.

• Average length of hospital stay was a secondary outcome measure.
• Average hospital costs were a secondary outcome measure.
• These outcomes were intended to assess the practical and economic impact of the intervention.

The authors acknowledge key limitations of the study design requiring further validation.

• The study is a single-center trial, which limits generalizability.
• The authors state that 'further validation through multi-center studies with larger sample sizes is still required.'
• The safety and efficacy of the anti-inflammatory diet in early nutritional management for mild pancreatitis 'remain to be evaluated' at the time of protocol publication.