Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial
Asian Pacific Weight Loss and Metabolic Surgery Center
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 9, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 8, 2012
May 1, 2012
7 months
September 1, 2011
May 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire of gastrointestinal quality of life
two weeks after taken drugs
Study Arms (1)
probiotic, lifestyle counseling
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- morbid obesity patients after gastric bypass with annoyed intestinal symptoms
You may not qualify if:
- cannot obey the orders to take medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WJ Lee
Taoyuan, Taoyuan County, 330, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
YAO W C, Phd
MSIRB
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Min-Sheng general hospital IRB
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 9, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
May 8, 2012
Record last verified: 2012-05