Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity; Quality of Life

• Registration Number: NCT02868489
• Lead Sponsor: Loma Linda University

Brief Summary

The purpose of the study is to determine the effect of bacillus coagulans and galactomannans (LactoWise®) administration on obese patients undergoing sleeve gastrectomy by observing standard protocol measurements in patients following sleeve gastrectomy: laboratory measurements, ideal body weight, and percent estimated weight loss, in addition incorporating the Gastrointestinal Quality of Life Index (GIQLI)

Detailed Description

Loma Linda University's School of Allied Health Professions in collaboration with the Metabolic and Bariatric Surgery Department under the Surgery Division is conducting research to evaluate the influence of LactoWise® (a proprietary blend of probiotic and prebiotic - bacillus coagulans/galactomannans, respectively) on the normal microbiota of obese patients post bariatric sleeve gastrectomy. Pre-surgery, participants will be required to sign a consent form and to complete the Gastro-Intestinal Quality of Life Index (GIQLI). A total of 60 bariatric sleeve patients will be recruited for this investigation. Post-surgery participants will be randomized into two groups, one will receive LactoWise® and one be the control (placebo). The LactoWise® blend has 300 mg of the bacillus coagulans and galactomannans and contains around 4.5 billion live cells. Daily intake of capsules coupled with bariatric sleeve standard of care will be conducted for the duration of 3 months, which is the anticipated clinical timeline. Participants will also be asked to complete the quality of life questionnaire at each of the following follow-ups post-surgery: 2nd week, 6th week, and 3rd month.

Outcome measures will be the standard protocol for bariatric sleeve patients at the Metabolic and Bariatric Surgery Department which will include weight measurements, blood work. In addition to the standard of care procedures a research procedure to be added is the GIQLI. Pre and post clinical consults, administration of probiotic/prebiotic formulae, and follow-ups will be conducted at the Faculty Medical Offices - General Surgery - Bariatric Clinic at Loma Linda University Health.

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2016-12-07
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient of bariatric sleeve surgery
• Ages 18-70
• Consent to complete GIQOL questionnaire
• Commit to consistent use of LactoWise® or placebo assigned for study period

Exclusion Criteria

• None sleeve bariatric surgery patient
• Have compromised immunity or poorly controlled systems
• Presence of any concurrent active infection
• Physically disabled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in weight percent EWL	Baseline - 3 months	Changes in weight expressed will be based off of the percent excess body weight loss (percentage EBWL) which is the weight loss relative to ideal weight expressed as a percentage. For the calculation of percentage EBWL the ideal body weight will be based off of BMI 25. BMI will be measured in kg/m\^2. Studies have shown that changes in the physical structure or manipulation of the gastrointestinal system may influence normal microbiota which can be characterized by changes in metabolism which in turn will be tested by changes in weight

Trial Locations

Locations (1)

Faculty of Medical Offices - LLU; 🇺🇸 Loma Linda, California, United States