Previously submitted to: JMIR Research Protocols (no longer under consideration since Nov 14, 2025)
Date Submitted: Jan 8, 2025
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Early oral anti-inflammatory diet in patients with mild acute pancreatitis：study protocol for a randomized controlled trial
ABSTRACT
Background:
Early oral feeding in patients with mild acute pancreatitis can facilitate early recovery and offer economic benefits such as reduced average length of hospital stay and hospitalization costs. However, there is a paucity of research on nutritional support protocols for early oral feeding in patients with acute pancreatitis. Anti-inflammatory diets have been shown to decrease inflammatory levels and modulate intestinal microbiota, which may confer advantages in early nutritional support for patients with acute pancreatitis.
Objective:
This study aims to explore the safety and effectiveness of early introduction of an anti-inflammatory diet in patients with mild acute pancreatitis.
Methods:
This is a single-center randomized controlled trial where the experimental group undergoes early oral anti-inflammatory diet intervention, while the control group receives conventional nutritional management. The primary outcome measures include levels of inflammatory biomarkers (C-reactive protein,interleukin-6, interleukin-10, and tumor necrosis factor-α, nutrition-related indicators (BMI, body composition, albumin, and prealbumin), and gut microbiota. Secondary outcome measures include the average length of hospital stay and average hospitalization costs.
Results:
The enrollment of study participants commenced in December 2024, with an anticipated completion date in July 2025. A comprehensive final analysis of the study outcomes is planned for October 2025, following the collection and rigorous evaluation of all relevant data.
Conclusions:
The positive findings of this study may offer novel clinical practice guidelines for early nutritional support in patients with mild acute pancreatitis. Clinical Trial: Chinese Clinical Trial Registry.gov ChiCTR2400094056；https://www.chictr.org.cn/index.html
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