Clostridium Butyricum MiyairiNCT03247101
Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial
A study testing Miyarisan-BM (Clostridium Butyricum Miyairi), Urso group and Biotase group in people with Clostridium Butyricum Miyairi and Gallstones, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial summary
Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Clostridium Butyricum Miyairi, Gallstones, Gastrointestinal Quality of Life Index
- What is being tested?
- Miyarisan-BM (Clostridium Butyricum Miyairi), Urso group and Biotase group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2016to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving bariatric surgery for morbid obesity
- Patiets at ages between 20 to 65 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.
About this study
Official title: Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective
Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. Previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. Therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life.
Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. It consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.
- Being tested
- Miyarisan-BM (Clostridium Butyricum Miyairi), Urso group, Biotase group
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miyarisan-BM (Clostridium Butyricum Miyairi)Drug
40mg po tid x 6months
Urso groupDrug
ursodoxycholic acid, 200mg po tid x 6 months
Biotase groupDrug
Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months Receives: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) |
| Urso group | Active comparator | ursodoxycholic acid, 200mg po tid x 6 months Receives: Drug: Urso group |
| Biotase group | Active comparator | Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months Receives: Drug: Biotase group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallstones formation
Measured: 6 months
Secondary outcomes (1)
serum total cholesterol and LDL level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Clostridium Butyricum MiyairiStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247101
- Sponsor's protocol ID
- MSIRB2016006
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.
PubMed 1858735Shiffman ML, Sugerman HJ, Kellum JH, Brewer WH, Moore EW. Gallstones in patients with morbid obesity. Relationship to body weight, weight loss and gallbladder bile cholesterol solubility. Int J Obes Relat Metab Disord. 1993 Mar;17(3):153-8.
PubMed 8385075Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. doi: 10.1016/0016-5085(92)91115-k.
PubMed 1612328Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. doi: 10.1381/096089293765559278.
PubMed 10757929Worobetz LJ, Inglis FG, Shaffer EA. The effect of ursodeoxycholic acid therapy on gallstone formation in the morbidly obese during rapid weight loss. Am J Gastroenterol. 1993 Oct;88(10):1705-10.
PubMed 8213711Han ML, Lee MH, Lee WJ, Chen SC, Almalki OM, Chen JC, Wu CC. Probiotics for gallstone prevention in patients with bariatric surgery: A prospective randomized trial. Asian J Surg. 2022 Dec;45(12):2664-2669. doi: 10.1016/j.asjsur.2022.01.120. Epub 2022 Feb 26.
PubMed 35232647
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective
- ClinicalTrials.gov ID
- NCT03247101
- Acronym / sponsor ID
- MSIRB2016006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Aug 2017 (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.
Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. Previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. Therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life.
Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. It consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.
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 |
|---|---|---|
| Probiotics group | Experimental | Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months |
| Urso group | Active comparator | Drug: Urso groupursodoxycholic acid, 200mg po tid x 6 months |
| Biotase group | Active comparator | Drug: Biotase groupBiotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving bariatric surgery for morbid obesity
- Patiets at ages between 20 to 65 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 |
|---|---|---|
| Miyarisan-BM (Clostridium Butyricum Miyairi)40mg po tid x 6months | Drug | Probiotics group |
| Urso groupursodoxycholic acid, 200mg po tid x 6 months | Drug | Urso group |
| Biotase groupBiotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months | Drug | Biotase group |
Primary outcome
Gallstones formation
Time frame: 6 months
1 secondary outcome
serum total cholesterol and LDL level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Results publication: PubMed 1858735Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.
- Results publication: PubMed 8385075Shiffman ML, Sugerman HJ, Kellum JH, Brewer WH, Moore EW. Gallstones in patients with morbid obesity. Relationship to body weight, weight loss and gallbladder bile cholesterol solubility. Int J Obes Relat Metab Disord. 1993 Mar;17(3):153-8.
- Results publication: PubMed 1612328Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. doi: 10.1016/0016-5085(92)91115-k.
- Results publication: PubMed 10757929Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. doi: 10.1381/096089293765559278.
- Results publication: PubMed 8213711Worobetz LJ, Inglis FG, Shaffer EA. The effect of ursodeoxycholic acid therapy on gallstone formation in the morbidly obese during rapid weight loss. Am J Gastroenterol. 1993 Oct;88(10):1705-10.
- Derived from this study: PubMed 35232647Han ML, Lee MH, Lee WJ, Chen SC, Almalki OM, Chen JC, Wu CC. Probiotics for gallstone prevention in patients with bariatric surgery: A prospective randomized trial. Asian J Surg. 2022 Dec;45(12):2664-2669. doi: 10.1016/j.asjsur.2022.01.120. Epub 2022 Feb 26.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miyarisan-BM (Clostridium Butyricum Miyairi), Urso group and Biotase group in people with Clostridium Butyricum Miyairi and Gallstones, run by Min-Sheng General Hospital at 1 site in Taiwan.
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 11 Aug 2017. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallstones formation (time frame: 6 months). 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 NCT03247101, which also lists 6 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 11 Aug 2017.