Dietary therapy for gallstone expulsion
A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial
This study is testing if a special diet can help people get rid of small gallstones without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hepatopancreatobiliary Surgery Institute of Gansu Province Academic / other |
| Locations | 1 site (Lanzhou, Gansu) |
| Trial ID | NCT06699030 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of dietary therapy in expelling gallstones, specifically targeting gallbladder sludge-like stones with a diameter of less than 2 mm. Conducted as a double-blind, prospective, single-center controlled trial at a tertiary hospital, the study aims to determine if functional fatty acids can facilitate the expulsion of these stones compared to a placebo. The trial addresses a significant gap in current treatment options, as there is limited research on non-surgical methods for gallstone management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with gallbladder sludge-like stones measuring less than 2 mm in diameter.
Not a fit: Patients with a history of gallstone removal surgery, significant gastrointestinal disorders, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive dietary approach to managing gallstones, potentially reducing the need for surgical interventions.
How similar studies have performed: While dietary approaches for gallstone management are not extensively studied, this trial explores a novel method that has not been previously validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm Exclusion Criteria: * History of ERCP (Endoscopic Retrograde Cholangiopancreatography) * Previous gallstone removal surgery with gallbladder preservation * History of acute or chronic pancreatitis, cholangitis * Mirizzi Syndrome * History of gastrointestinal surgery * Gastrointestinal obstruction * Dysfunction of the sphincter of Oddi * Gallbladder neck polyps * Abnormal gallbladder structure * Gallbladder mass * Biliary infection or stones * Congenital biliary abnormalities * Biliary injury or surgery * Biliary tumors * Gastrointestinal bleeding, liver cirrhosis, or other malignant diseases * Significant arrhythmia, bradycardia, or atrioventricular block * Severe hypertension, liver or kidney insufficiency * Immune, endocrine, hematological, or mental disorders * Severe cerebrovascular disease * Allergy to relevant foods * Pregnant or breastfeeding women * Unwillingness or inability to consent to participation
Where this trial is running
Lanzhou, Gansu
- Long Deng — Lanzhou, Gansu, China (Recruiting)
Study contacts
- Principal investigator: Wenbo Meng, M.D. — Hepatopancreatobiliary Surgery Institute of Gansu Province
- Study coordinator: Wenbo Meng, M.D.
- Email: mengwb@lzu.edu.cn
- Phone: 13919177177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.