Functional fatty acid-based dietary therapy as a new strategy for small gallstone expulsion: study protocol for a...

Gallstone disease is a major global health concern with a steadily increasing prevalence, affecting approximately 7% of the global population and imposing substantial health and economic burdens. Globally, gallstone disease accounts for 10-15% of all gastrointestinal hospital admissions, with annual direct medical costs exceeding $6 billion in the United States and ¥20 billion in China, primarily driven by cholecystectomy and post-surgical complications. According to clinical observations, oral administration of olive oil may facilitate the expulsion of small gallstones; however, high-quality evidence supporting this dietary therapy remains limited. In our preliminary study, a 6-day regimen of orally administered functional fatty acids effectively promoted the elimination of small gallstones.

This study aims to evaluate the efficacy and safety of oral functional fatty acid supplementation for facilitating the expulsion of small gallbladder stones, and to assess its potential as a noninvasive therapeutic option. The primary endpoint is the complete expulsion rate of small gallbladder stones at day 3 post-intervention, confirmed by two independent blinded ultrasound technologists. The complete expulsion rate at day 6 post-intervention is designated as a key secondary endpoint.

This prospective, single-center, double-blind, randomized controlled trial will enroll 100 adult patients with ultrasonographically confirmed small gallstones (maximum diameter <2 mm) and no prior treatment history. Participants will be randomly assigned at a 1:1 ratio to either the intervention group (n = 50), which will receive 50 mL of functional fatty acids daily on an empty stomach for 6 consecutive days, or the control group (n = 50), which will receive placebo for the first 3 days followed by the same dose of functional fatty acids for the subsequent 3 days. Abdominal ultrasound examinations will be performed on days 3 and 6 post-intervention to assess gallstone expulsion. Adverse events, including nausea, vomiting, abdominal pain, diarrhea, and signs of biliary obstruction, will be closely monitored throughout the study period.

If proven effective, this intervention could provide a noninvasive alternative to surgery for patients with small gallstones, inform clinical practice, and help reduce the healthcare burden associated with gallstone disease.

ClinicalTrials.gov, identifier: NCT06699030.