ObesityNCT02868489
Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy
A study testing LactoWise® in people with Obesity and Quality of Life, run by Loma Linda University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Quality of Life
- What is being tested?
- LactoWise®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2016to 29 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None sleeve bariatric surgery patient
- Have compromised immunity or poorly controlled systems
- Presence of any concurrent active infection
- Physically disabled
Trial locations and contacts
1 site in 1 country.
United States1 site
Faculty of Medical Offices - LLU
Loma Linda, California, 92354
About this study
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)
Read the 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
- Being tested
- LactoWise®, Placebo
- Keywords
- Microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoWise®Dietary supplement
Also called blend of bacillus coagulans and galactomannans
blend of bacillus coagulans and galactomannans
PlaceboOther
Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start7 Dec 2016
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Scharf, DO, Loma Linda University
- Investigators
- Keith Scharf, DO FACS, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868489
- Sponsor's protocol ID
- 5160281
- Status last verified
- Sep 2021
- First submitted
- 28 Jul 2016
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19381735
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02868489
- Acronym / sponsor ID
- 5160281
- Conditions
- Obesity, Quality of Life
- Keywords
- Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprietary Blend - LactoWise® | Experimental | Dietary Supplement: 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. |
| Control | Placebo comparator | Other: PlaceboFor 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- None sleeve bariatric surgery patient
- Have compromised immunity or poorly controlled systems
- Presence of any concurrent active infection
- Physically disabled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoWise®Also: blend of bacillus coagulans and galactomannansblend of bacillus coagulans and galactomannans | Dietary supplement | Proprietary Blend - LactoWise® |
| PlaceboPlacebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate) | Other | Control |
Primary outcome
Changes in weight percent EWL
Time frame: Baseline - 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 19381735Woodard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Scharf, DO FACS principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LactoWise® in people with Obesity and Quality of Life, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weight percent EWL (time frame: Baseline - 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.