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

NCT ID: NCT02868489

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-07
• Study Completion Date: 2017-11-29

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.

Conditions

Obesity; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Proprietary Blend - LactoWise®

After being randomized into two groups, the assigned experimental group, prior to surgery and after consenting, will be asked to complete the Gastrointestinal Quality of Life Index. In addition the experimental group will be given their supply of LactoWise®. They will be required to take 1 capsule per day (300 mg of bacillus coagulans and galactomannans at 4.5 billion live cells) at breakfast consistently for 3 months. There will be three follow up visits (Week-2, Week-6 and Month-3) where participants will be asked to complete the gastrointestinal quality of life index.

Group Type: EXPERIMENTAL

LactoWise®

Intervention Type: DIETARY_SUPPLEMENT

blend of bacillus coagulans and galactomannans

Control

For the control group, prior to surgery and after consenting to enroll in the study participants will also be asked to complete the Gastrointestinal Quality of Life Index. Participants of the control group will be administered their supply of a matching placebo. They will be required to take 1 capsule per day at breakfast consistently for 3 months. There will be three follow up visits (Week-2, Week-6 and Month-3) where participants will be asked to complete the gastrointestinal quality of life index.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)

Interventions

LactoWise®

blend of bacillus coagulans and galactomannans

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)

Intervention Type: OTHER

Other Intervention Names

blend of bacillus coagulans and galactomannans

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Keith Scharf, DO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Scharf, DO FACS

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Faculty of Medical Offices - LLU

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19381735 (View on PubMed)

Other Identifiers

5160281

Identifier Type: -

Identifier Source: org_study_id