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

BACKGROUND: The anti-inflammatory diet exerts its effects by suppressing inflammatory mediators and modulating gut microbiota to reduce inflammation. However, its safety and efficacy in early nutritional management for patients with mild pancreatitis remain to be evaluated. OBJECTIVE: This study aims to evaluate both the efficacy and safety of an early introduction of an anti-inflammatory diet in patients with mild acute pancreatitis. METHODS: This single-center randomized controlled trial enrolled 72 patients with mild acute pancreatitis (revised Atlanta criteria), randomly assigning 36 patients to each group. The intervention group received an early oral anti-inflammatory diet protocol featuring: ① oral intake initiation within 48 h; ② the daily food intake followed a diet with a Dietary Inflammatory Index (DII) score of less than 0, as formulated by the research group. The control group received conventional management: physician-directed oral intake initiation and a stepwise advancement from "clear liquid to full liquid to low-fat soft diet." Primary outcomes included inflammatory biomarkers, nutritional indicators, and gut microbiota (16S rRNA sequencing). Secondary outcomes were average hospital stay and costs. DISCUSSION: The positive findings of this study may offer novel clinical practice guidelines for early nutritional support in patients with mild acute pancreatitis. However, as a single-center study, further validation through multi-center studies with larger sample sizes is still required. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400094056. https://www.chictr.org.cn/index.html .