Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06699030

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

Led by Hepatopancreatobiliary Surgery Institute of Gansu Province · Updated on 2025-12-31

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Gallstones are a common health issue, and their occurrence has been increasing worldwide. This research aims to evaluate whether dietary therapy can help in expelling early-stage gallstones, specifically those present in a sludge-like form, which currently lack effective treatment options. The trial is a double-blind, prospective study conducted at a single medical center to investigate this question. Participants are randomly assigned to receive either functional fatty acids or a placebo orally. The treatment period lasts six days, with the experimental group taking functional fatty acids throughout. The placebo group receives placebo for the first three days, followed by functional fatty acids for the next three days. This design allows comparison of gallstone expulsion effectiveness between the groups. During the study, participants will undergo assessments including sonographic evaluation of gallbladder sludge expulsion after three and six days, as well as measurements of gallbladder volume and wall thickness. Researchers will also monitor blood bilirubin levels and observe any post-intervention symptoms such as abdominal pain, acute pancreatitis, gastrointestinal bleeding, nausea, vomiting, and diarrhea. The study period and follow-up span up to two weeks, ensuring thorough safety and outcome monitoring.

CONDITIONS

Brief Title

A Strategy for Gallstone Expulsion Through Dietary Therapy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
  • Age between 18 and 70 years
  • Ability to consent to participation
Not Eligible

You will not qualify if you...

  • History of Endoscopic Retrograde Cholangiopancreatography (ERCP)
  • Previous gallstone removal surgery with gallbladder preservation
  • History of acute or chronic pancreatitis or cholangitis
  • Presence of Mirizzi Syndrome
  • History of gastrointestinal surgery
  • Gastrointestinal obstruction
  • Dysfunction of the sphincter of Oddi
  • Presence of gallbladder neck polyps
  • Abnormal gallbladder structure
  • Presence of 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 days

Participants receive oral administration of functional fatty acids or placebo to evaluate gallstone expulsion.

1 baseline visit and 1 follow-up visit

Follow-up

Duration - 8 days

Participants are monitored for gallbladder condition and potential side effects such as abdominal pain, acute pancreatitis, gastrointestinal bleeding, nausea, vomiting, and diarrhea.

Visits up to Day 14 post-intervention

Trial Site Locations

Total: 1 location

1

Long Deng

Lanzhou, Gansu, China, 730000

Actively Recruiting

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Research Team

W

Wenbo Meng, M.D.

L

Long Deng, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Ursodeoxycholic acid for the prevention of gallstones and subsequent cholecystectomy after bariatric surgery: a meta-analysis of randomized controlled trials.

Andrea Mulliri, Benjamin Menahem, Arnaud Alves...

https://pubmed.ncbi.nlm.nih.gov/35704084