NCT02868489

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LactoWise®	blend of bacillus coagulans and galactomannans
OTHER	Placebo	Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)

Timeline

• Start date: 2016-12-07
• Primary completion: 2017-11-29
• Completion: 2017-11-29
• First posted: 2016-08-16
• Last updated: 2021-09-24

Locations

1 site across 1 country: United States