A Strategy for Gallstone Expulsion Through Dietary Therapy

A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial

This study is a double-blind, prospective, single-center controlled trial conducted at a tertiary hospital, aiming to determine whether dietary therapy can effectively expel gallstones.

Study Overview

• Status: Recruiting
• Conditions: Gallbladder Stone
• Intervention / Treatment: Drug: Functional fatty acids; Other: Placebo

Detailed Description

Gallstones are a common clinical condition, and their prevalence has been increasing globally in recent years. Gallstone formation is a result of various combined factors, and in its early stages, gallstones often exist in a sludge-like form. Currently, there is no definitive research on whether gallbladder sludge can be effectively expelled through medication or dietary therapy. Therefore, the investigators are conducting a double-blind, prospective, single-center controlled trial to verify whether gallbladder sludge-like stones can be effectively expelled using dietary therapy.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbo Meng, M.D.; Phone Number: 13919177177; Email: mengwb@lzu.edu.cn
• Study Contact Backup: Name: Long Deng, M.D.; Phone Number: 13893192432; Email: ldyy_longdengld@lzu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Recruiting
      • Long Deng
      • Principal Investigator: Wenbo Meng, MD,PhD
      • Contact: Long Deng, M.D,; Phone Number: 13893192432; Email: ldyy_longdengld@lzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional fatty acids; Oral Administration of functional fatty acids	Drug: Functional fatty acids; Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
Placebo Comparator: Placebo; Oral Administration of Placebo	Other: Placebo; Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with complete expulsion of gallbladder sludge after three days of intervention	Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled	7 days
2）Number of patients with complete expulsion of gallbladder sludge after six days of intervention	Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder Volume	Measured by ultrasound (L × W × D × 0.52)	7 days
Gallbladder Wall Thickness	Measured by ultrasound, accurate to 0.1 mm	7 days
Serum bilirubin	Determined by lab examination within 3.4-17.1μmol/L	7 days
Presence of Abdominal Pain Post-Intervention	If abdominal pain is present, it will be assessed using the Numerical Rating Scale (NRS) within 0-10, The higher the score, the more serious it is	7 days
Occurrence of Acute Pancreatitis Post-Intervention	Pain and Amy >3times as normal	14 days
Occurrence of Gastrointestinal Bleeding Post-Intervention	Black stool or decrease of HB	14 days
Nausea, Vomiting, and Diarrhea Post-Intervention	Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention	14 days

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General Publications

• Zhuang Q, Cheng J, Xia J, Ning M, Wu S, Shen S, Shi Y, Huang D, Dong Z, Wan X. Gypenosides Prevent and Dissolve Cholesterol Gallstones by Modulating the Homeostasis of Cholesterol and Bile Acids. Front Med (Lausanne). 2022 Apr 4;9:818144. doi: 10.3389/fmed.2022.818144. eCollection 2022.
• Mulliri A, Menahem B, Alves A, Dupont B. Ursodeoxycholic acid for the prevention of gallstones and subsequent cholecystectomy after bariatric surgery: a meta-analysis of randomized controlled trials. J Gastroenterol. 2022 Aug;57(8):529-539. doi: 10.1007/s00535-022-01886-4. Epub 2022 Jun 15.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cholecystitis; Gallstone; Gallbladder Function; Ultrasound Examination
• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Pathological Conditions, Signs and Symptoms; Cholecystitis; Gallstones; Cholecystolithiasis
• Other Study ID Numbers: Gallstone Expulsion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No