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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868489
• Other study ID #: 5160281
• Status: Completed
• Phase: N/A
• Start date: December 7, 2016
• Est. completion date: November 29, 2017

Study information

• Verified date: September 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Quality of Life

Intervention

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)

Locations

Country	Name	City	State
United States	Faculty of Medical Offices - LLU	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woodard GA, Encarnacion B, Downey JR, Peraza J, Chong K, Hernandez-Boussard T, Morton JM. Probiotics improve outcomes after Roux-en-Y gastric bypass surgery: a prospective randomized trial. J Gastrointest Surg. 2009 Jul;13(7):1198-204. doi: 10.1007/s11605-009-0891-x. Epub 2009 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight percent EWL	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	Baseline - 3 months