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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Min-Sheng General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
WEI-CHENG YAO, Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT01431651
First received: September 1, 2011
Last updated: May 5, 2012
Last verified: May 2012
  Purpose

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 Intervention
Morbid Obesity
Dietary Supplement: probiotics,digestive enzyme

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Asian Pacific Weight Loss and Metabolic Surgery Center

Resource links provided by NLM:


Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:
  • Questionnaire of gastrointestinal quality of life [ Time Frame: two weeks after taken drugs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbid obesity patients after gastric bypass with annoyed intestinal symptoms

Exclusion Criteria:

  • cannot obey the orders to take medicine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431651

Contacts
Contact: Lee W J, Doctor +8863179599 ext 1599 wjlee_obessurg_tw@yahoo.com.tw
Contact: Chen J C, Phd +88693179599 ext 8320 M001540@e-ms.com.tw

Locations
Taiwan
WJ Lee Recruiting
Taoyuan city, Taoyuan county, Taiwan, 330
Contact: Lee W J, Doctor    +8863179599 ext 1599    M001529@e-ms.com.tw   
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Study Director: YAO W C, Phd MSIRB
  More Information

No publications provided

Responsible Party: WEI-CHENG YAO, Min-Sheng general hospital IRB, Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT01431651     History of Changes
Other Study ID Numbers: MSIRB2011010
Study First Received: September 1, 2011
Last Updated: May 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Min-Sheng General Hospital:
Food and beverages
Food
Dietary supplements

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

ClinicalTrials.gov processed this record on September 15, 2014