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Dietary therapy as a new strategy for gallstone expulsion: Study protocol for a prospective, single-center, double-blind, randomized controlled trial
ABSTRACT
Background:
Gallstone disease is a major global health concern with a steadily increasing prevalence, posing substantial health and economic burdens. According to clinical observations, the oral administration of edible oils may facilitate the expulsion of small gallstones. However, evidence supporting the efficacy of such a dietary therapy is limited. In a preliminary study, we observed that a 6-day regimen of orally administered functional fatty acids, primarily composed of medium- and long-chain triglycerides, effectively promoted the elimination of small gallstones. To further evaluate the potential of this type of therapy, we designed a randomized controlled trial to generate preliminary clinical evidence supporting the efficacy of functional fatty acid supplementation in facilitating the expulsion of small gallstones.
Objective:
Our specific objective will be to observe and record changes in the number of small gallbladder stones in the experimental group and the control group 3 days and 6 days after intervention—primarily on ultrasound—and to calculate their expulsion rates.
Methods:
This prospective, single-center, double-blind, randomized controlled trial will include adult patients with ultrasonographically confirmed small gallstones and no prior history of treatment. Participants will be randomly assigned at a 1:1 ratio to either the intervention group (n = 50), which will receive a 6-day course of functional fatty acids, or the control group (n = 50), which will receive a dietary regimen consisting of 3 days of placebo followed by 3 days of functional fatty acids. Ultrasound examinations will be performed on days 3 and 6 after the intervention to confirm and quantify the expulsion of small gallstones, along with related parameters. Adverse events, including nausea, vomiting, abdominal pain, diarrhea, and signs of biliary obstruction, will be closely monitored throughout the study period.
Results:
Recruitment for this trial commenced on June 1, 2025. As of October 2025, a total of 21 participants have been enrolled, and the data remains unanalyzed.
Conclusions:
The aim of this study is to assess the efficacy of functional fatty acids in promoting the expulsion of small gallstones and thus to evaluate its potential as a noninvasive therapeutic option. If proven effective, this intervention could inform clinical practice and help reduce the healthcare burden associated with gallstone disease. Clinical Trial: ClinicalTrials.gov/Identifier: NCT06699030. Registered on 16 November 2024.
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