Gallbladder StoneNCT06699030
A Strategy for Gallstone Expulsion Through Dietary Therapy
A study testing Functional fatty acids in people with Gallbladder Stone, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Stone
- What is being tested?
- Functional fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Long Deng
Lanzhou, Gansu, 730000
Long Deng, M.D,, 13893192432, ldyy_longdengld@lzu.edu.cn
Wenbo Meng, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gallbladder Stone
- Being tested
- Functional fatty acids, Placebo
- Keywords
- Gallstone, Gallbladder Function, Cholecystitis, Ultrasound Examination
- Medical subject headings
- Cholecystolithiasis, Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional fatty acidsDrug
Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
PlaceboOther
Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Functional fatty acids | Experimental | Oral Administration of functional fatty acids Receives: Drug: Functional fatty acids |
| Placebo | Placebo comparator | Oral Administration of Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days
Secondary outcomes (7)
Gallbladder Volume
Measured by ultrasound (L × W × D × 0.52)
Measured: 7 days
Gallbladder Wall Thickness
Measured by ultrasound, accurate to 0.1 mm
Measured: 7 days
Serum bilirubin
Determined by lab examination within 3.4-17.1μmol/L
Measured: 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
Measured: 7 days
Occurrence of Acute Pancreatitis Post-Intervention
Pain and Amy >3times as normal
Measured: 14 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Black stool or decrease of HB
Measured: 14 days
Nausea, Vomiting, and Diarrhea Post-Intervention
Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start24 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gallbladder StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699030
- Sponsor's protocol ID
- Gallstone Expulsion
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35445045Mulliri 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.
PubMed 35704084Deng 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.
PubMed 42490892
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06699030
- Acronym / sponsor ID
- Gallstone Expulsion
- Conditions
- Gallbladder Stone
- Keywords
- Gallstone, Gallbladder Function, Cholecystitis, Ultrasound Examination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Functional fatty acids | Experimental | Drug: Functional fatty acidsOral Administration of functional fatty acids |
| Placebo | Placebo comparator | Other: PlaceboOral Administration of Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional fatty acidsDays 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids | Drug | Functional fatty acids |
| PlaceboDays 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids | Other | Placebo |
Primary outcome
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）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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 35445045Zhuang 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.
- Background: PubMed 35704084Mulliri 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.
- Derived from this study: PubMed 42490892Deng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenbo Meng, M.D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional fatty acids in people with Gallbladder Stone, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbo Meng, M.D. (13919177177, mengwb@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete expulsion of gallbladder sludge after three days of intervention (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.