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A Strategy for Gallstone Expulsion Through Dietary Therapy

NCT ID: NCT06699030

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Gallbladder Stone

Keywords

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Gallstone Gallbladder Function Cholecystitis Ultrasound Examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double (Investigator, Participant)

Study Groups

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Functional fatty acids

Oral Administration of functional fatty acids

Group Type EXPERIMENTAL

Functional fatty acids

Intervention Type DRUG

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

Placebo

Oral Administration of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Functional fatty acids

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Wenbo Meng

Director of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenbo Meng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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Long Deng

Lanzhou, Gansu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenbo Meng, M.D.

Role: CONTACT

Phone: 13919177177

Email: [email protected]

Long Deng, M.D.

Role: CONTACT

Phone: 13893192432

Email: [email protected]

Facility Contacts

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Long Deng, M.D,

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35445045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35704084 (View on PubMed)

Other Identifiers

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Gallstone Expulsion

Identifier Type: -

Identifier Source: org_study_id