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Clinical Trials/NCT01431651
NCT01431651UnknownNot Applicable

Asian Pacific Weight Loss and Metabolic Surgery Center

Min-Sheng General Hospital1 site in 1 country60 target enrollmentStarted: October 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Questionnaire of gastrointestinal quality of life

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •morbid obesity patients after gastric bypass with annoyed intestinal symptoms

Exclusion Criteria

  • •cannot obey the orders to take medicine

Arms & Interventions

probiotic, lifestyle counseling

Experimental

Intervention: probiotics,digestive enzyme (Dietary Supplement)

Outcomes

Primary Outcomes

Questionnaire of gastrointestinal quality of life

Time Frame: two weeks after taken drugs

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

WEI-CHENG YAO

Min-Sheng general hospital IRB

Min-Sheng General Hospital

Study Sites (1)

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