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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431651
Recruitment Status : Unknown
Verified May 2012 by WEI-CHENG YAO, Min-Sheng General Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2011
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
WEI-CHENG YAO, Min-Sheng General Hospital

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Dietary Supplement: probiotics,digestive enzyme Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Asian Pacific Weight Loss and Metabolic Surgery Center
Study Start Date : October 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: probiotic, lifestyle counseling 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

Primary Outcome Measures :
  1. Questionnaire of gastrointestinal quality of life [ Time Frame: two weeks after taken drugs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431651

Contact: Lee W J, Doctor +8863179599 ext 1599
Contact: Chen J C, Phd +88693179599 ext 8320

WJ Lee Recruiting
Taoyuan city, Taoyuan county, Taiwan, 330
Contact: Lee W J, Doctor    +8863179599 ext 1599   
Sponsors and Collaborators
Min-Sheng General Hospital
Study Director: YAO W C, Phd MSIRB

Responsible Party: WEI-CHENG YAO, Min-Sheng general hospital IRB, Min-Sheng General Hospital Identifier: NCT01431651     History of Changes
Other Study ID Numbers: MSIRB2011010
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by WEI-CHENG YAO, Min-Sheng General Hospital:
Food and beverages
Dietary supplements

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms