Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial

Morbid Obesity Clinical Trial

Official title:

Asian Pacific Weight Loss and Metabolic Surgery Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01431651
• Other study ID #: MSIRB2011010
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2011
• Last updated: May 5, 2012
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Min-Sheng General Hospital
• Contact: Lee W J, Doctor
• Phone: +8863179599
• Email: wjlee_obessurg_tw[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• morbid obesity patients after gastric bypass with annoyed intestinal symptoms

Exclusion Criteria:

• cannot obey the orders to take medicine

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• probiotics,digestive enzyme
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

Locations

Country	Name	City	State
Taiwan	WJ Lee	Taoyuan city	Taoyuan county

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire of gastrointestinal quality of life		two weeks after taken drugs	Yes