Clinical trial NCT02868489: Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy
Official title: Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Quality of Life
Keywords: Microbiota
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in weight percent EWL
timeFrame: Baseline - 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Faculty of Medical Offices - LLU
state: California
Study officials:
affiliation: Loma Linda University Health
name: Keith Scharf, DO FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.