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NCT Number: NCT06699030

A Strategy for Gallstone Expulsion Through Dietary Therapy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Deng

Lanzhou, Gansu, 730000, China

Location status: Recruiting

Location contact

Long Deng, M.D,

CONTACT

[email protected]

13893192432

Wenbo Meng, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional fatty acids

Drug

Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids

Placebo

Other

Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids

Primary outcomes

  1. Number of patients with complete expulsion of gallbladder sludge after three days of intervention

    Time frame: 7 days

    Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled

  2. 2)Number of patients with complete expulsion of gallbladder sludge after six days of intervention

    Time frame: 7 days

    Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled

Secondary outcomes

  1. Gallbladder Volume

    Time frame: 7 days

    Measured by ultrasound (L × W × D × 0.52)

  2. Gallbladder Wall Thickness

    Time frame: 7 days

    Measured by ultrasound, accurate to 0.1 mm

  3. Serum bilirubin

    Time frame: 7 days

    Determined by lab examination within 3.4-17.1μmol/L

  4. Presence of Abdominal Pain Post-Intervention

    Time frame: 7 days

    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

  5. Occurrence of Acute Pancreatitis Post-Intervention

    Time frame: 14 days

    Pain and Amy >3times as normal

  6. Occurrence of Gastrointestinal Bleeding Post-Intervention

    Time frame: 14 days

    Black stool or decrease of HB

  7. Nausea, Vomiting, and Diarrhea Post-Intervention

    Time frame: 14 days

    Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Long Deng, M.D.

CONTACT

[email protected]

13893192432

Wenbo Meng, M.D.

CONTACT

[email protected]

13919177177

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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