<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03247101</url>
  </required_header>
  <id_info>
    <org_study_id>MSIRB2016006</org_study_id>
    <nct_id>NCT03247101</nct_id>
  </id_info>
  <brief_title>Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial</brief_title>
  <official_title>Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Min-Sheng General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Min-Sheng General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Morbid obesity has become a major global health problem, and the use of bariatric surgery is&#xD;
      increasing. One common complication seen following bariatric surgery is the formation of&#xD;
      gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder&#xD;
      and supersaturation of bile due to rapid weight loss and mobilization of cholesterol.&#xD;
      Previous studies revealed oral probiotics could reduce the cholesterol level by as much as&#xD;
      22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of&#xD;
      cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and&#xD;
      physiological actions of the end products of short chain fatty acid fermentation. Therefore,&#xD;
      the aim of this study was to determine the ability of probiotics to prevent gallstones&#xD;
      formation after bariatric surgery and to evaluate the impact of oral administration of&#xD;
      probiotics on the post bariatric surgery patients 's quality of life.&#xD;
&#xD;
      Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the&#xD;
      quality of life for patients receiving bariatric surgery. It consists of five domains:&#xD;
      digestive symptoms; physical function; emotional condition; social condition and effect of&#xD;
      medical treatment, which could access the quality of life of bariatric patient effectively&#xD;
      and completely.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gallstones formation</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum total cholesterol and LDL level</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Clostridium Butyricum Miyairi</condition>
  <condition>Gallstones</condition>
  <condition>Gastrointestinal Quality of Life Index</condition>
  <arm_group>
    <arm_group_label>Probiotics group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urso group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ursodoxycholic acid, 200mg po tid x 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biotase group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miyarisan-BM (Clostridium Butyricum Miyairi)</intervention_name>
    <description>40mg po tid x 6months</description>
    <arm_group_label>Probiotics group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urso group</intervention_name>
    <description>ursodoxycholic acid, 200mg po tid x 6 months</description>
    <arm_group_label>Urso group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Biotase group</intervention_name>
    <description>Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months</description>
    <arm_group_label>Biotase group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients receiving bariatric surgery for morbid obesity&#xD;
&#xD;
          2. Patiets at ages between 20 to 65 y/o&#xD;
&#xD;
          3. Patients willing to follow up regulary after bariatric surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients having gallstones before bariatric surgery&#xD;
&#xD;
          2. Patients refusing taking probiotics or refusing regular follow up after bariatric&#xD;
             surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Min sheng general hospital</name>
      <address>
        <city>Taoyuan city</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>1858735</PMID>
  </results_reference>
  <results_reference>
    <citation>Shiffman 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.</citation>
    <PMID>8385075</PMID>
  </results_reference>
  <results_reference>
    <citation>Shiffman 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.</citation>
    <PMID>1612328</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams 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.</citation>
    <PMID>10757929</PMID>
  </results_reference>
  <results_reference>
    <citation>Worobetz 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.</citation>
    <PMID>8213711</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03247101
org study id: MSIRB2016006
nct id: NCT03247101
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Gallstones formation
time frame: 6 months
measure: serum total cholesterol and LDL level
time frame: 6 months
arm group label: Probiotics group
arm group type: Experimental
description: Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months
arm group label: Urso group
arm group type: Active Comparator
description: ursodoxycholic acid, 200mg po tid x 6 months
arm group label: Biotase group
arm group type: Active Comparator
description: Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
intervention type: Drug
intervention name: Miyarisan-BM (Clostridium Butyricum Miyairi)
description: 40mg po tid x 6months
arm group label: Probiotics group
intervention type: Drug
intervention name: Urso group
description: ursodoxycholic acid, 200mg po tid x 6 months
arm group label: Urso group
intervention type: Drug
intervention name: Biotase group
description: Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
arm group label: Biotase group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
citation: 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.
PMID: 1858735
citation: Shiffman 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.
PMID: 8385075
citation: Shiffman 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.
PMID: 1612328
citation: Williams 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.
PMID: 10757929
citation: Worobetz 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.
PMID: 8213711
responsible party type: Sponsor
mesh term: Gallstones
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
sharing ipd: Undecided