NCT02868489

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

July 28, 2016

Last Update Submit

September 21, 2021

Conditions

ObesityQuality of Life

Keywords

Microbiota

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Proprietary Blend - LactoWise®

EXPERIMENTAL

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.

Dietary Supplement: LactoWise®

Control

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

LactoWise®DIETARY_SUPPLEMENT

blend of bacillus coagulans and galactomannans

Also known as: blend of bacillus coagulans and galactomannans
Proprietary Blend - LactoWise®
PlaceboOTHER

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

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None sleeve bariatric surgery patient
  • Have compromised immunity or poorly controlled systems
  • Presence of any concurrent active infection
  • Physically disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medical Offices - LLU

Loma Linda, California, 92354, United States

Location

Related 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.

    PMID: 19381735BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

galactomannan

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Keith Scharf, DO FACS

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 16, 2016

Study Start

December 7, 2016

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)