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

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.

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