Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
probiotics,digestive enzyme
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Food and beverages, Food, Dietary supplements
Eligibility Criteria
Inclusion Criteria:
- morbid obesity patients after gastric bypass with annoyed intestinal symptoms
Exclusion Criteria:
- cannot obey the orders to take medicine
Sites / Locations
- WJ LeeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
probiotic, lifestyle counseling
Arm Description
Outcomes
Primary Outcome Measures
Questionnaire of gastrointestinal quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT01431651
First Posted
September 1, 2011
Last Updated
May 5, 2012
Sponsor
Min-Sheng General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01431651
Brief Title
Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial
Official Title
Asian Pacific Weight Loss and Metabolic Surgery Center
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Min-Sheng General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight loss and resolution of metabolic co-morbidities in morbidly obese patients .
However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine whether probiotics would improve annoyed GI symptoms after gastric bypass.
Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." Probiotics are available to consumers mainly in the form of dietary supplements and foods.
Detailed Description
Probiotics are available in foods and dietary supplements (for example, capsules, tablets, and powders) and in some other forms as well. Examples of foods containing probiotics are yogurt, fermented and unfermented milk, miso, and some juices and soy beverages. In probiotic foods and supplements, the bacteria may have been present originally or added during preparation. In this study, we investigate the efficacy of probiotics for alleviating the annoyed GI symptoms after LGB.
Clostridium butyricum Probiotics is a novel microecological feed additive, it has the characteristic of heat tolerance, acid tolerance and antibiotic resistance and is general used to treat the intestinal tract disease in the clinical treatment. Its potential function in the situation that feed has been added universally with antibiotics will make it have a good development.
This randomized, placebo-controlled, double blind, prospective clinical trial was conducted among 60 patients undergoing gastric bypass for morbid obesity who had annoyed GI symptoms. Patients were randomized to the clostridium butyricum MIYAIRI group (80 mg daily , n=20,), bifidobacterium Longum BB536 group (2 packs daily, n=20),and biotase group(4 tablets daily, n=20). Control group (Biotase per day). Quality of life was measured and compared by the gastro-intestinal quality of life index (GIQLI) before and two weeks after in both groups. The higher score means that they have better quality of life. Through this study, we hope that we can find a effective probiotics can help all the patient received gastric bypass and bothered by their gastrointestinal problems also can improve their satisfaction of this operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Food and beverages, Food, Dietary supplements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotic, lifestyle counseling
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics,digestive enzyme
Intervention Description
patients was randomized into 3 groups: clostridium butyricum MIYAIRI group (80 mg daily) bifidobacterium Longum BB536 group (2 packs daily) biotase:4 tables per day
Primary Outcome Measure Information:
Title
Questionnaire of gastrointestinal quality of life
Time Frame
two weeks after taken drugs
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morbid obesity patients after gastric bypass with annoyed intestinal symptoms
Exclusion Criteria:
cannot obey the orders to take medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee W J, Doctor
Phone
+8863179599
Ext
1599
Email
wjlee_obessurg_tw@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chen J C, Phd
Phone
+88693179599
Ext
8320
Email
M001540@e-ms.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YAO W C, Phd
Organizational Affiliation
MSIRB
Official's Role
Study Director
Facility Information:
Facility Name
WJ Lee
City
Taoyuan city
State/Province
Taoyuan county
ZIP/Postal Code
330
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee W J, Doctor
Phone
+8863179599
Ext
1599
Email
M001529@e-ms.com.tw
12. IPD Sharing Statement
Learn more about this trial
Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial
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