Bariatric Surgery CandidateNCT06287931
Probiotics for Gallstones in Post-bariatric Surgery Patients
A study testing Ursodoxycholic acid group and Bifidobacterium group in people with Bariatric Surgery Candidate and Gallstone, run by Shandong Linglong Yingcheng Hospital at 1 site in China.
Trial summary
Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Gallstone, Gallstone Attack
- What is being tested?
- Ursodoxycholic acid group and Bifidobacterium group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients receiving bariatric surgery for morbid obesity
- Patiets at ages between 20 to 60 y/o
- Patients willing to follow up regulary after bariatric surgery
Who cannot join
- Patients having gallstones before bariatric surgery
- Patients refusing taking probiotics or refusing regular follow up after bariatric surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, 264000
Xuan Qiu, MD, 8618354280081, qiuxuan100@163.com
Ni Wang, MD, 8618705353551, wangni1989@163.com
About this study
Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.
- Conditions
- Bariatric Surgery Candidate, Gallstone, Gallstone Attack, Gastrointestinal Quality of Life Index, Probiotics
- Being tested
- Ursodoxycholic acid group, Bifidobacterium group
- Keywords
- Bariatric Surgery Candidate, Gallstone, Probiotics
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodoxycholic acid groupDrug
Ursodoxycholic acid, 250mg po tid x 6 months
Bifidobacterium groupDrug
Bifidobacteria, 210 mg po tid x 6 months
| Study group | Role | What they receive |
|---|---|---|
| Ursodoxycholic acid group | Experimental | Ursodoxycholic acid, 250mg po tid x 6 months Receives: Drug: Ursodoxycholic acid group |
| Bifidobacterium group | Experimental | Bifidobacteria, 210 mg po tid x 6 months Receives: Drug: Bifidobacterium group |
| Bifidobacterium and ursodeoxycholic acid group | Experimental | Ursodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months Receives: Drug: Ursodoxycholic acid group; Drug: Bifidobacterium group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of gallstones in bariatric surgery patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Linglong Yingcheng Hospital
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Xuan Qiu, Shandong Linglong Yingcheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287931
- Sponsor's protocol ID
- sdllycyy001
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Gallstones in Post-bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT06287931
- Acronym / sponsor ID
- sdllycyy001
- Conditions
- Bariatric Surgery Candidate, Gallstone, Gallstone Attack, Gastrointestinal Quality of Life Index, Probiotics
- Keywords
- Bariatric Surgery Candidate, Gallstone, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shandong Linglong Yingcheng HospitalResearch network
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Mar 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.
Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ursodoxycholic acid group | Experimental | Drug: Ursodoxycholic acid groupUrsodoxycholic acid, 250mg po tid x 6 months |
| Bifidobacterium group | Experimental | Drug: Bifidobacterium groupBifidobacteria, 210 mg po tid x 6 months |
| Bifidobacterium and ursodeoxycholic acid group | Experimental | Drug: Ursodoxycholic acid group, Drug: Bifidobacterium groupUrsodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients receiving bariatric surgery for morbid obesity
- Patiets at ages between 20 to 60 y/o
- Patients willing to follow up regulary after bariatric surgery
Key exclusion criteria (2 listed)
- Patients having gallstones before bariatric surgery
- Patients refusing taking probiotics or refusing regular follow up after bariatric 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 |
|---|---|---|
| Ursodoxycholic acid groupUrsodoxycholic acid, 250mg po tid x 6 months | Drug | Bifidobacterium and ursodeoxycholic acid group, Ursodoxycholic acid group |
| Bifidobacterium groupBifidobacteria, 210 mg po tid x 6 months | Drug | Bifidobacterium and ursodeoxycholic acid group, Bifidobacterium group |
Primary outcome
The incidence of gallstones in bariatric surgery patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodoxycholic acid group and Bifidobacterium group in people with Bariatric Surgery Candidate and Gallstone, run by Shandong Linglong Yingcheng Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuan Qiu, MD (8618354280081, qiuxuan100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gallstones in bariatric surgery patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.