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Recruiting NCT06699030

A Strategy for Gallstone Expulsion Through Dietary Therapy

No phase Interventional Gallbladder Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional fatty acids, Placebo.
Who it may be relevant to
Registry conditions: Gallbladder Stone. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Drug Functional fatty acids
    Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
  • Other Placebo
    Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids

Primary outcome measures

  • Number of patients with complete expulsion of gallbladder sludge after three days of intervention [Time frame: 7 days]
  • 2）Number of patients with complete expulsion of gallbladder sludge after six days of intervention [Time frame: 7 days]
Secondary outcome measures (7)
  • Gallbladder Volume [Time frame: 7 days]
  • Gallbladder Wall Thickness [Time frame: 7 days]
  • Serum bilirubin [Time frame: 7 days]
  • Presence of Abdominal Pain Post-Intervention [Time frame: 7 days]
  • Occurrence of Acute Pancreatitis Post-Intervention [Time frame: 14 days]
  • Occurrence of Gastrointestinal Bleeding Post-Intervention [Time frame: 14 days]
  • Nausea, Vomiting, and Diarrhea Post-Intervention [Time frame: 14 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Long Deng — Lanzhou

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. PMID 35445045
  • 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. PMID 35704084
  • Deng L, Xu H, Zhang B, Jin K, Yue P, Lin Y, Peng P, Melloul E, Yuan J, Meng W. Functional fatty acid-based dietary therapy as a new strategy for small gallstone expulsion: study protocol for a prospective, single-center, double-blind, randomized controlled trial. Front Nutr. 2026 Jul 3;13:1859377. doi: 10.3389/fnut.2026.1859377. eCollection 2026. PMID 42490892

Identifiers

NCT: NCT06699030 · Gallstone Expulsion

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗